ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00070109
Conditions: Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Peripheral Primitive Neuroectodermal Tumor
Sponsor: Children's Oncology Group
Start date: 2008-01-01; Completion date: 2013-12-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743 (trabectedin).

II. Determine the toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.

OUTLINE:

Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 5 years.

Arms: arm 1: Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level. arm 2: Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment. arm 3: Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. arm 4: Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. arm 5: Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: trabectedin intervention 2: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00077207
Conditions: Brain Tumor Central Nervous System Tumor
Keywords: untreated childhood cerebellar astrocytoma untreated childhood visual pathway and hypothalamic glioma childhood spinal cord neoplasm childhood oligodendroglioma childhood low-grade cerebral astrocytoma
Sponsor: Children's Oncology Group
Start date: 2004-07-01; Completion date: 2013-12-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.

Detailed description:
OBJECTIVES:

Primary

* Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas.

Secondary

* Determine response rate in patients treated with this regimen.
* Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
* Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

OUTLINE: This is a pilot study.

* Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy.
* Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Arms: arm 1: Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
Interventions: intervention 1: carboplatin intervention 2: temozolomide intervention 3: vincristine sulfate
Intervention descriptions: intervention 1: Given IV intervention 2: Given orally intervention 3: Given IV

Protocol documents:
Clinical trial NCT00171873
Conditions: Neuroendocrine Tumors
Keywords: Double blind Phase III Disease Clinical trial Octreotide Neuroendocrine tumor Cancer Tumor Midgut
Sponsor: Carmen Schade-Brittinger
Start date: 2001-09-01; Completion date: 2013-12-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

Detailed description:

Arms: arm 1: Octreotide LAR 30 mg intramuscularly every 28 days arm 2: Placebo - Sodium chloride intramuscularly every 28 days
Interventions: intervention 1: Octreotide LAR (Long-acting release) intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg intramuscularly every 28 days intervention 2: Sodium chloride intramuscularly every 28 days

Protocol documents:
Clinical trial NCT00267696
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: ovarian cancer platinum sensitive cancer fallopian tube cancer peritoneal cancer
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2005-11-01; Completion date: 2013-12-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.

Detailed description:
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.

Arms: arm 1: A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Interventions: intervention 1: Bevacizumab intervention 2: Gemcitabine intervention 3: Carboplatin
Intervention descriptions: intervention 1: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. intervention 2: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle intervention 3: None

Protocol documents:
Clinical trial NCT00295867
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: University of California, San Francisco
Start date: 2004-11-03; Completion date: 2013-12-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Zoledronate may delay or prevent bone marrow metastases in patients with breast cancer.

PURPOSE: This phase II trial is studying how well zoledronate works in treating bone marrow micrometastases in women with stage I, stage II, or stage III breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response of bone marrow micrometastases, as measured by immunocytochemistry/flow cytometry (IC/FC), during and after 2 years of treatment with zoledronate in women with stage I-III breast cancer.

Secondary

* Evaluate the effects of zoledronate on the bone osteoclast activation marker, n-telopeptide, in these patients.
* Evaluate the incidence of distant recurrences in high-risk women with early-stage breast cancer and bone marrow micrometastases who receive adjuvant zoledronate.

OUTLINE: This is a pilot study.

Patients receive zoledronate IV over 15 minutes once a month for 2 years in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Arms: arm 1: Patients women with early stage breast cancer and evidence of occult malignant cells in bone marrow aspirates following adjuvant chemotherapy will receive zoledronic acid (Zometa) 4mg, given intravenously over 15 minutes, once a month for two years.
Interventions: intervention 1: Zoledronic Acid
Intervention descriptions: intervention 1: Zoledronic acid is a new, highly potent, heterocyclic nitrogen-containing third generation bisphosphonate that has demonstrated 40- to 850- fold greater potency than pamidronate in preclinical models of bone resorption. The mechanism of action of nitrogen-containing bisphosphonates such as pamidronate and zoledronic acid appears to involve inhibition of the mevalonate pathway

Protocol documents:
Clinical trial NCT00303459
Conditions: Pulmonary Arterial Hypertension
Keywords: sildenafil Combination Drug Therapy bosentan Pulmonary Hypertension Pulmonary Arterial Hypertension Multicenter Study Antihypertensive Agents Tracleer endothelin receptor antagonist Randomized Controlled Trial Phosphodiesterase type 5 inhibitor (PDE5i) Outcome Assessment
Sponsor: Actelion
Start date: 2006-05-01; Completion date: 2013-12-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized.

The study continued until the predefined target number of morbidity/mortality events was reached.

Detailed description:

Arms: arm 1: Bosentan arm 2: Placebo
Interventions: intervention 1: bosentan intervention 2: placebo
Intervention descriptions: intervention 1: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d. intervention 2: Matching bosentan placebo/b.i.d.

Protocol documents:
Clinical trial NCT00311584
Conditions: Neuroblastoma
Keywords: recurrent neuroblastoma
Sponsor: Children's Oncology Group
Start date: 2006-04-01; Completion date: 2013-12-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in pediatric patients with relapsed neuroblastoma (NB) treated with irinotecan hydrochloride and temozolomide.
* Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen.

Secondary

* Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy.
* Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients.
* Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies.
* Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis.
* Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease status (measurable disease \[measured by conventional CT scan and/or MRI\] vs evaluable disease \[tumor detected by conventional morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on MIBG scan\]).

Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. arm 2: Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: irinotecan hydrochloride intervention 2: temozolomide
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00333229
Conditions: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
Keywords: Breast Cancer premenopausal Bone Mineral density Cancer therapy induced bone loss zoledronic acid
Sponsor: Novartis Pharmaceuticals
Start date: 2006-03-01; Completion date: 2013-12-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover.

This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.

This study is not recruiting patients in the United States.

Detailed description:

Arms: arm 1: Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months. arm 2: Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials. intervention 2: Matching Placebo

Protocol documents:
Clinical trial NCT00356811
Conditions: Neoplasms, Breast
Keywords: Lapatinib Metastatic breast cancer Paclitaxel ErbB2-amplification GW572016
Sponsor: GlaxoSmithKline
Start date: 2006-05-01; Completion date: 2013-12-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study investigates the safety and efficacy of oral lapatinib in combination with an approved medication, paclitaxel, for patients with ErbB2 metastatic breast cancer.

Detailed description:

Arms: arm 1: Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.
Interventions: intervention 1: Lapatinib oral tablets intervention 2: Paclitaxel infusion
Intervention descriptions: intervention 1: Lapatinib will be given as tablets contain 410 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base per tablet. Subjects will be given a 4 week supply of lapatinib tables and instructed to take 6 tablets daily (1500 mg daily dose) orally at the same time each day. Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. intervention 2: Subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle). Subjects will be treated with paclitaxel for at least 6 months, and may continue on paclitaxel at the discretion of the Investigator, or discontinued sooner if the subject has disease progression, an unacceptable toxicity or withdraws consent.

Protocol documents:
Clinical trial NCT00374556
Conditions: Osteoarthritis Insomnia
Keywords: eszopiclone insomnia
Sponsor: Johns Hopkins University
Start date: 2006-01-01; Completion date: 2013-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.

Detailed description:

Arms: arm 1: Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks arm 2: 3mg placebo capsule, once daily at bedtime for 12 weeks
Interventions: intervention 1: Placebo intervention 2: Eszopiclone
Intervention descriptions: intervention 1: 3mg placebo capsule, once daily at bedtime intervention 2: 3mg capsule, once daily at bedtime

Protocol documents:
Clinical trial NCT00401778
Conditions: Lung Cancer
Keywords: Lung Cancer
Sponsor: Emory University
Start date: 2006-11-01; Completion date: 2013-12-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate the target effects of this compounds on relevant molecular pathways and on the 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) uptake of the tumor by a positron emission tomography (PET) scan at baseline and immediately prior to surgery. The safety profile of RAD001 will also be evaluated.

Detailed description:
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the novel agent in relevant molecular pathways. The study will also assess the FDG uptake of the tumor at baseline and upon completion of therapy (before surgery) with a PET scan. The safety profile of RAD001 will also be evaluated.

New agents and regimens are urgently needed for lung cancer treatment. With the development of novel agents and small molecules designed to curtail the aggressive aspects of this disease, some progress has been realized. However, much more effort and insight will be required for further real gains to be made. We propose that studying the mammalian target of rapamycin (mTOR) axis, known to be abnormal in non-small cell lung cancer (NSCLC), and translating that knowledge into therapeutic adjustments can lead to meaningful advances in lung cancer treatment.

Approximately 35 patients will participate at Winship Cancer Institute of Emory University in Atlanta, Georgia.

Arms: arm 1: RAD001 5 mg/day for 21 days sequentially. arm 2: RAD001 10 mg/day for 21 days sequentially. arm 3: Patients who are eligible for the study but choose not to receive RAD001 treatment.
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: Patients will be assigned to one of three treatment arms with RAD001 doses of 5, and 10 mg/day for 21-28 days sequentially taken orally in tablet form.

Protocol documents:
Clinical trial NCT00470275
Conditions: Sarcoma
Keywords: recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
Sponsor: Children's Oncology Group
Start date: 2007-05-01; Completion date: 2013-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.

Detailed description:
OBJECTIVES:

* Determine the response rate in younger patients with recurrent or refractory Ewing's sarcoma treated with cytarabine.

OUTLINE: This is a multicenter study.

Patients receive cytarabine IV over 2 hours twice daily on days 1-5. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Arms: arm 1: Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
Interventions: intervention 1: cytarabine
Intervention descriptions: intervention 1: Given IV

Protocol documents: