ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00045032
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2001-11-01; Completion date: 2015-06-01
Enrollment: 5099 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Detailed description:

Arms: arm 1: Participants who have completed definitive surgery and systemic adjuvant chemotherapy will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin will be provided. arm 2: Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 1 year or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. arm 3: Participants who have completed definitive surgery and systemic adjuvant chemotherapy will receive Herceptin for 2 years or until disease recurrence, whichever occurs first. Participants will be observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
Interventions: intervention 1: Herceptin intervention 2: Herceptin
Intervention descriptions: intervention 1: Herceptin will be given as a loading dose of 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks. intervention 2: Herceptin will be given as a loading dose of 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks.

Protocol documents:
Clinical trial NCT00096044
Conditions: Leukemia
Keywords: refractory chronic lymphocytic leukemia
Sponsor: Roswell Park Cancer Institute
Start date: 2004-03-01; Completion date: 2015-06-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.

Detailed description:
OBJECTIVES:

Primary

* Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leukemia treated with lenalidomide (CC-5013).

Secondary

* Determine the cytostatic response rate in patients who progress on CC-5013 and are then treated with CC-5013 and rituximab.
* Determine the safety of these regimens in these patients.
* Determine time to progression in patients treated with these regimens.

OUTLINE: This is an open-label, non-randomized, pilot study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.

Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.

Arms: arm 1: Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: rituximab intervention 2: lenalidomide
Intervention descriptions: intervention 1: IV intervention 2: Oral

Protocol documents:
Clinical trial NCT00444678
Conditions: Colorectal Cancer Neoplasm Metastasis
Keywords: Previously untreated metastatic colorectal cancer Metastatic Colorectal Cancer combined therapy biologics therapy antibody chemotherapy EGFR epidermal growth factor receptor
Sponsor: NYU Langone Health
Start date: 2004-06-01; Completion date: 2015-06-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.

Detailed description:
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV (fluorouracil/leucovorin) in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a chimeric monoclonal antibody against the growth factor receptor, has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone. Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx (capecitabine plus oxaliplatin) regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use.

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin intervention 3: Capecitabine
Intervention descriptions: intervention 1: 500 mg/m2, IV every two weeks intervention 2: 85 mg/m2, IV, q 2 weeks intervention 3: 2500 mg, po bid x 7 days every two weeks

Protocol documents:
Clinical trial NCT00503984
Conditions: Prostate Cancer Pain
Keywords: Adenocarcinoma of the prostate Recurrent prostate cancer Stage IV prostate cancer Pain
Sponsor: University of Miami
Start date: 2007-05-01; Completion date: 2015-06-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.

Detailed description:
Study design A phase I/II clinical trial in patients with hormone refractory metastatic prostate cancer.

Primary objective phase I component of study:

To determine a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.

Primary objective phase II component of study:

To determine the therapeutic efficacy of combined therapy of azacitidine, docetaxel, and prednisone, in the treatment of hormone refractory metastatic prostate cancer. The primary measure of therapeutic efficacy is response, defined as prostate-specific antigen (PSA) response, complete response (CR), or partial response (PR).

Secondary endpoints are toxicity, duration of response, progression-free survival, and overall survival.

Arms: arm 1: Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim). arm 2: Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
Interventions: intervention 1: Azacitidine intervention 2: Docetaxel intervention 3: Prednisone intervention 4: GADD45α methylation and expression analysis intervention 5: Pegfilgrastim intervention 6: Filgrastim
Intervention descriptions: intervention 1: Intravenous infusion over 30 minutes Days 1 - 5 of each 3 weekly cycle. intervention 2: Intravenous infusion over 1 hour on day 6 of each 3 weekly cycle. intervention 3: Patient will receive prednisone 5mg twice a day from Day 1 to 21 of each cycle. intervention 4: Peripheral blood samples from patients will be collected as described in section 8.1 (total of 4 blood samples). DNA will be isolated from serum, bisulfite treated and evaluated for methylation by bisulfite genomic sequencing.

Patients with accessible prostate tissue or metastases will undergo biopsy prior to treatment if they consent to do so. intervention 5: Growth factor support.Granulocyte-colony stimulating factor (G-CSF) intervention 6: Growth factor support. Granulocyte-colony stimulating factor (G-CSF)

Protocol documents:
Clinical trial NCT00582075
Conditions: Cancer Brain Metastases
Keywords: Cancer Brain metastases Gamma Knife Radiosurgery Temodar Temozolomide
Sponsor: University of Alabama at Birmingham
Start date: 2002-07-01; Completion date: 2015-06-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The protocol is designed to determine the efficacy of temozolomide in preventing the development of new brain metastases within the first year in patients undergoing stereotactic radiation for newly diagnosed brain metastases.

Detailed description:
This is a phase II study. The primary endpoint is the proportion of patients with newly developed metastases who develop new brain metastases within the first year of undergoing stereotactic radiation combined with the administration of temozolamide within the first year post treatment. Retrospective and prospective studies suggest that 50- 60% of long-term survivors develop new brain metastases. Since it is important to observe all patients recruited for a minimum of a year to measure the primary outcome, traditional phase 2 designs such as Simon's two stage optimal design or the mini-max design are not practical in this case. Survival and QOL are secondary end points. QOL will be measured using the Functional Assessment of Cancer Therapy (FACT -BR). It will be administered at baseline, at week four and every three months for 24 months.

This protocol includes radiosurgery with standard radiation doses (15-24 Gy based upon RTOG 9005). Patient may be registered after radiosurgery as long as Temodar is started within two weeks of radiosurgery.

Beginning within two weeks after radiosurgery: TMZ 200mg/m2 days 1-5 repeat q28 days. Patients who have received prior chemotherapy will receive 150 mg/m2 days 1-5.

Temozolomide is continued until there is disease progression defined by systemic progression or new metastases. If lesion treated with radiosurgery progresses in the absence of new CNS tumors or systemic progression, then TMZ will continue. Temozolomide is discontinued for systemic progression requiring other systemic chemotherapy.

Palliative radiation may be administered to non-CNS sites during protocol treatment, but additional systemic chemotherapy will not be administered until patients progress systemically or until new metastases develop.

Arms: arm 1: None
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: TMZ 200mg/m2 days 1-5 repeat q28 days. Patients who have received prior chemotherapy will receive 150 mg/m2 days 1-5

Protocol documents:
Clinical trial NCT00588952
Conditions: Alcoholism
Sponsor: Yale University
Start date: 2001-03-01; Completion date: 2015-06-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high-risk individuals that may lead to the transition from moderate to excessive use of alcohol.

Detailed description:
Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to decrease dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to ketamine infusion when compared to family history negative (FHN) control subjects.

Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 2 test days in a randomized balanced order under double-blind conditions. Test days will involve the 60-minute intravenous infusion of placebo and ketamine. Outcome measures include the Biphasic Alcohol Scale and visual analog scales for mood states. Secondary measures include visual analog scales for high, similarity to ethanol, the Sensation Scale (a validated measure of ethanol-like sensations) and aspects of craving for alcohol.

Arms: arm 1: Subjects with a positive family history of alcoholism arm 2: Subjects with a negative family history of alcoholism
Interventions: intervention 1: Ketamine and Placebo
Intervention descriptions: intervention 1: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes

Protocol documents:
Clinical trial NCT00612352
Conditions: Alcoholism
Sponsor: Yale University
Start date: 2001-03-01; Completion date: 2015-06-01
Enrollment: 180 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high risk individuals that may lead to the transition from moderate to excessive use of alcohol.

Detailed description:
Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to alcohol infusion when compared to family history negative (FHN) control subjects.

Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 3 test days in a randomized balanced order under double-blind conditions. Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for over 60 minutes. Outcome measures include the Positive and Negative Symptom Scale, visual analog scales of mood state, (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) to measure perceptual responses to alcohol. Secondary measures include visual analog scales for high, similarity to ethanol, Mini Mental Status Examination (MMSE), Placement of electrodes, Biphasic Alcohol Effects Scale, Hopkins Verbal Learning, and number of drinks scale, aspects of craving for alcohol and tests of cognitive impairment.

Arms: arm 1: Subjects with a positive family history of alcoholism. arm 2: Subjects with a negative family history of alcoholism.
Interventions: intervention 1: Ethanol High Dose, Ethanol Low Dose, and Placebo
Intervention descriptions: intervention 1: Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.

Protocol documents:
Clinical trial NCT00634582
Conditions: Metastatic Cancer Prostate Cancer
Keywords: adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer bone metastases
Sponsor: Wake Forest University Health Sciences
Start date: 2009-01-01; Completion date: 2015-06-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.

PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.

Detailed description:
OBJECTIVES:

Primary

* To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases.

Secondary

* To explore the relationship between paricalcitol therapy and markers of bone resorption in these patients.

OUTLINE: Patients receive oral paricalcitol once daily for 10 weeks in the absence of unacceptable toxicity.

Patients undergo blood sample collection periodically to determine markers of bone formation and resorption by ELISA; parathyroid hormone (PTH) levels by immunometric assay; prostate-specific antigen (PSA) levels by immunoassay; and 25-hydroxyvitamin D and 1,25(OH)\_2D levels by radioimmunoassay.

Patients also undergo a bone densitometry (DEXA scan) at baseline and at 10 weeks to assess changes in bone strength.

Quality of life is assessed prior to, during, and after completion of treatment. Questionnaires include the Pain Inventory, the Brief Pain Inventory, the Functional Assessment of Cancer Therapy-G (FACT-G), and the Analgesic Use Diary (Narcotic Pain Medication Logbook).

After completion of study treatment, patients are followed every 6 months for 1 year.

Interventions: intervention 1: paricalcitol intervention 2: immunoenzyme technique intervention 3: laboratory biomarker analysis intervention 4: dual x-ray absorptometry intervention 5: quality-of-life assessment
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00661531
Conditions: Breast Cancer Cancer of the Breast Neoplasms, Breast
Keywords: Breast cancer Metastatic breast cancer ER positive breast cancer Hormonal therapy
Sponsor: Georgetown University
Start date: 2008-04-01; Completion date: 2015-06-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.

Detailed description:
Prior to the current standard of care utilizing estrogen deprivation or antiestrogen therapy to treat hormonally sensitive breast cancers, treatment with pharmacologic doses of estrogen was a common technique used to treat post-menopausal women with hormone sensitive metastatic disease that resulted in durable responses with regression of disease. A randomized trial comparing tamoxifen and pharmacologic doses of estrogen demonstrated similar rates of response with long-term follow-up data confirming a survival benefit for those treated with the estrogen preparation. Additional data has shown that post-menopausal women with hormonally sensitive tumors that have progressed on prior endocrine therapies responded to treatment with pharmacologic doses of estrogen. These data, coupled with pre-clinical data that postmenopausal levels of estrogen can be used to cause apoptosis (programmed cell death within the tumor) and tumor regression in exhaustively treated endocrine resistant disease form the rationale for the proposed clinical trial. This trial seeks to confirm the response rate for estrace treatment in a patient population heavily pre-treated with modern endocrine therapies.

Arms: arm 1: Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
Interventions: intervention 1: Estrace intervention 2: Anastrozole
Intervention descriptions: intervention 1: Estrace 10 mg three times daily will be administered for 3 months. intervention 2: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment

Protocol documents: