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5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Diagnostic (FLT PET) secondary trial: Arm A All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Diagnostic (FLT PET) secondary trial: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Diagnostic (FLT PET) secondary trial: Arm B All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Diagnostic (FLT PET) secondary trial: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan. secondary trial: Arm A All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan. secondary trial: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan. secondary trial: Arm B All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan. secondary trial: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine. secondary trial: Arm A All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine. secondary trial: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine. secondary trial: Arm B All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine. secondary trial: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Positron Emission Tomography: Undergo FLT PET secondary trial: Arm A All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Positron Emission Tomography: Undergo FLT PET secondary trial: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Positron Emission Tomography: Undergo FLT PET secondary trial: Arm B All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Positron Emission Tomography: Undergo FLT PET secondary trial: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen. secondary trial: Arm A All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen. secondary trial: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen. secondary trial: Arm B All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
5bc844fc-e852-4270-bfaf-36ea9eface3d
primary trial: Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen. secondary trial: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO All the primary trial participants do not receive any oral capecitabine, oral lapatinib ditosylate or cixutumumab IV, in conrast all the secondary trial subjects receive these.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Histologically or cytologically confirmed infiltrating breast cancer Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Clinical evidence of metastatic disease Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Measurable disease, defined as at lePatients with histologic confirmation of invasive breast carcinoma.ast one measurable lesion per RECIST criteria Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following: Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Bone lesions Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Leptomeningeal disease Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Ascites Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Pleural/pericardial effusion Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Inflammatory breast disease Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Lymphangitis cutis/pulmonis Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Abdominal masses that are not confirmed and followed by imaging techniques Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Cystic lesions Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab Patients with Platelet count over 100,000/mm¬¨‚â•, ANC < 1,700/mm¬¨‚â• and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
CNS metastasis controlled by prior surgery and/or radiotherapy allowed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Must be asymptomatic for 2 months with no evidence of progression prior to study entry Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Hormone receptor status not specified Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
PATIENT CHARACTERISTICS: Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Menopausal status not specified Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Life expectancy 12 weeks Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
ECOG performance status 0-1 Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
ANC 1,500/mm³ Patients with Platelet count over 100,000/mm¬¨‚â•, ANC < 1,700/mm¬¨‚â• and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Platelet count 100,000/mm³ Patients with Platelet count over 100,000/mm¬¨‚â•, ANC < 1,700/mm¬¨‚â• and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Hemoglobin 9.0 g/dL Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
AST and ALT 2.5 times upper limit of normal (ULN) Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Alkaline phosphatase 2.5 times ULN Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Total bilirubin 1.5 times ULN Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Creatinine 1.5 mg/dL Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Not pregnant or nursing Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Negative pregnancy test Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Fertile patients must use effective contraception during and for 30 days after completion of study therapy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Able to complete questionnaires alone or with assistance Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No peripheral neuropathy > grade 1 Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No stage III or IV invasive, non-breast malignancy within the past 5 years Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Patient must not be receiving other specific treatment for a prior malignancy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart) Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No bleeding diathesis or uncontrolled coagulopathy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No hemoptysis within the past 6 months Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No prior arterial or venous thrombosis within the past 12 months Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No history of cerebrovascular accident Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No history of hypertensive crisis or hypertensive encephalopathy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No abdominal fistula or gastrointestinal perforation within the past 6 months Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No serious non-healing wound, ulcer, or fracture Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No clinically significant cardiac disease, defined as any of the following: Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Congestive heart failure Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Symptomatic coronary artery disease Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Unstable angina Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Cardiac arrhythmias not well controlled with medication Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Myocardial infarction within the past 12 months Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
PRIOR CONCURRENT THERAPY: Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
See Disease Characteristics Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No prior chemotherapy for metastatic disease Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
May have received one prior adjuvant chemotherapy regimen Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Prior neoadjuvant chemotherapy allowed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Prior hormonal therapy in either adjuvant or metastatic setting allowed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation) Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid) Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 1 week since prior minor surgery (e.g., core biopsy) Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Placement of a vascular access device within 7 days is allowed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
More than 3 months since prior neurosurgery Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
86b7cb3d-6186-4a04-9aa6-b174ab764eed
Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed Patients with Platelet count over 100,000/mm³, ANC < 1,700/mm³ and Hemoglobin between 4 to 5 grams per deciliter are eligible for the primary trial.
0
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Total: 285/752 (37.90%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Anaemia 2/752 (0.27%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Disseminated intravascular coagulation 2/752 (0.27%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Febrile neutropenia 51/752 (6.78%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Neutropenia 47/752 (6.25%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Thrombocytopenia 2/752 (0.27%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Atrial fibrillation 1/752 (0.13%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
dbed5471-c2fc-45b5-b26f-430c9fa37a37
primary trial: Total: 5/32 (15.63%) secondary trial: Atrial flutter 0/752 (0.00%) Heart-related adverse events were recorded in both the primary trial and the secondary trial.
1
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