ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00091026
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2004-07-01; Completion date: 2011-01-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying bevacizumab, gemcitabine, and cetuximab to see how well they work compared to bevacizumab, gemcitabine, and erlotinib in treating patients with advanced pancreatic cancer. Monoclonal antibodies, such as cetuximab and bevacizumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells.

Detailed description:
OBJECTIVES:

I. Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib.

II. Compare the toxicity of these regimens in these patients. III. Compare median progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center (University of Chicago vs other) and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.

Arm II: Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 54-126 patients (27-63 per treatment arm) will be accrued for this study within 16 months.

Arms: arm 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15. arm 2: Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
Interventions: intervention 1: cetuximab intervention 2: gemcitabine hydrochloride intervention 3: bevacizumab intervention 4: erlotinib hydrochloride
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given orally

Protocol documents:
Clinical trial NCT00114166
Conditions: Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
Sponsor: Gynecologic Oncology Group
Start date: 2005-01-01; Completion date: 2011-01-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.

PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
* Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

* Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
* Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

Arms: arm 1: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy arm 2: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
Interventions: intervention 1: topotecan hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00117598
Conditions: Lymphoma
Keywords: Lymphoma
Sponsor: Pfizer
Start date: 2005-05-01; Completion date: 2011-01-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Temsirolimus (CCI-779) intervention 2: Temsirolimus (CCI-779) intervention 3: Investigator's choice
Intervention descriptions: intervention 1: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week intervention 2: Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week intervention 3: Any of the following single agent treatments:

1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
7. Prednisone 40 (20-60) mg/m2 PO daily or every other day
8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day

Protocol documents:
Clinical trial NCT00122460
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-12-01; Completion date: 2011-01-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) intervention 2: Platinum (Cisplatin or Carboplatin) + 5-FU
Intervention descriptions: intervention 1: Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks intervention 2: All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks

Protocol documents:
Clinical trial NCT00129272
Conditions: Tobacco Use Cessation Tobacco Use Disorder
Keywords: adolescents, cigarettes, smoking, tobacco
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2004-05-01; Completion date: 2011-01-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Detailed description:
Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.

Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment.

Arms: arm 1: Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period. arm 2: Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Interventions: intervention 1: Bupropion-SR intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg tablets taken orally twice daily for 9 weeks. intervention 2: Matching placebo (to Buproion-SR) twice daily for 9 weeks.

Protocol documents:
Clinical trial NCT00131469
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis Imperfecta Brittle Bone Disease Fragility Fractures
Sponsor: Oregon Health and Science University
Start date: 2005-06-01; Completion date: 2011-01-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI).

Detailed description:
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI). Osteogenesis imperfecta is an inherited disorder of type I collagen, a major component of bones, and is characterized by multiple fractures and deformities. OI affects approximately 1-2 of every 10,000 individuals. Virtually all of the studies of potential treatments for OI have evaluated the effects of medications only on children with OI. There is no cure for osteogenesis imperfecta and there is no established medical therapy for adults with the disorder. There are very limited data concerning the usefulness of parathyroid hormone therapy in OI. An effective anabolic therapy for the treatment of adult patients with OI could be a valuable asset to the affected patients. In this study, the working hypothesis is that individuals affected with OI who are treated with Forteo will experience increased spine and hip bone mineral density and an increase in bone strength. Although Forteo is not expected to change the defect in the collagen produced, but is postulated to increase the quantity of bone formed and improve bone strength.

This will be a placebo controlled, double blinded trial; half the patients will receive Forteo 20 ug/day SQ. Adult patients (age at least 18 yrs) with OI will be enrolled for a treatment duration of 18 months. Blood, urine, and bone density/strength tests will be done during the study to assess efficacy and safety.

Arms: arm 1: Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months arm 2: Daily SQ placebo for 18 months
Interventions: intervention 1: Teriparatide (FORTEO) intervention 2: Placebos
Intervention descriptions: intervention 1: Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily intervention 2: None

Protocol documents:
Clinical trial NCT00181714
Conditions: ADHD
Keywords: cigarette smoking ADHD adolescents Concerta
Sponsor: Massachusetts General Hospital
Start date: 2003-11-01; Completion date: 2011-01-01
Enrollment: 203 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD.

The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.

Detailed description:

Arms: arm 1: Single arm- open treatment with extended duration methylphenidate (OROS MPH)
Interventions: intervention 1: methylphenidate HCl (Concerta)
Intervention descriptions: intervention 1: OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.

Protocol documents:
Clinical trial NCT00194077
Conditions: Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2004-08-01; Completion date: 2011-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

Detailed description:
This outpatient study will be conducted in 3 phases. Phase 1: Patients meeting entry criteria will be treated with open label aripiprazole (APZ) in order to achieve therapeutic doses of this agent. The primary objective of this phase is to stabilize the patient's mood prior to randomization in phase 2. Adjunctive treatment of attention-deficit hyperactivity disorder (ADHD) will be permitted during this phase after week 6 of phase 1. In order to be entered into Phase 2, patients must be clinically stable based on a priori criteria (see below). The maximum allowable duration of Phase 1 will be 16 weeks. Only patients who have achieved syndromal remission (not just improvement) will be eligible for randomization into phase 2.

Phase 2: Patients that achieve syndromal remission during Phase 1 will be randomized in a double-blind fashion to receive either ongoing APZ therapy or placebo therapy during Phase 2. Patients who are receiving co-administration of ADHD pharmacotherapy may continue with this during Phase 2. Patients will have an equal chance of being assigned to each of the 2 treatment arms. Randomization strata will be based on whether or not the subject is receiving ADHD pharmacotherapy and whether or not the subject is suffering from Bipolar 1 or 2 disorders. The maximum length of time a patient may remain in phase 2 will be 72 weeks. Youths who develop a major depressive episode, a manic, or mixed episode, or youths for whom continued enrollment in this phase of study is contraindicated (as determined by the patient, guardian, research team or study physician), will be withdrawn from phase 2. Youths who withdraw from phase 2 may enter Phase 3. Reason for removal from phase 2 will be documented. For those youths who successfully complete 72 weeks of participation in phase 2, trial participation will be ended. Those patients who complete phase 2 will receive follow up clinical care either at University Hospitals-Cleveland (UHC) or with a community-based physician.

Phase 3: For youths who are withdrawn during phase 2, 8-weeks of open-label treatment with APZ will be available

Arms: arm 1: Phase I and Phase III are open label Abilify phases where all subjects receive active Abilify arm 2: in Phase 2 subjects are randomized to either placebo or abilify for up to 72 weeks
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: dosing will occur at 2mg, 5mg, 7mg, 10 mg, 12mg, or 15 mg based on weight, side effects and efficacy intervention 2: subjects in phase 2 will be randomized to active abilify or placebo

Protocol documents:
Clinical trial NCT00275028
Conditions: Fallopian Tube Cancer Primary Peritoneal Serous Adenocarcinoma Recurrent Ovarian Epithelial Cancer Stage I Ovarian Epithelial Cancer Stage II Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2011-01-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD2171 works in treating patients with recurrent ovarian, peritoneal, or fallopian tube cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the efficacy of AZD2171 in platinum sensitive and platinum insensitive disease, based on either RECIST criteria (for patients with measurable cancer radiographically) or clinical response benefit (modified Gynecologic Cancer Intergroup \[GCIG\] CA-125 response or stable disease for at least 16 weeks).

SECONDARY OBJECTIVES:

I. To assess progression-free survival. II. To assess modified GCIG CA-125 response rate. III. To assess duration of modified GCIG CA-125 response. IV. To assess the safety of the recommended phase 2 dose of AZD2171 in this asymptomatic patient population.

V. To explore the pharmacodynamic effects of AZD2171 by correlating clinical outcomes with an angiogenic profile derived from serial assessments of soluble VEGFR2, circulating endothelial cell levels, and VEGFR phosphorylation in circulating endothelial cells.

VI. To explore pharmacogenetic differences in kdr/flk-1, HIF1alpha, p53, and endothelial nitric oxide synthase (eNOS) in PBMCs from subjects who consent separately for pharmacogenetic studies.

VII. To determine whether oncogenic mutations predict response to AZD2171.

OUTLINE: This is a multicenter study. Patients are stratified according to disease sensitivity (platinum-sensitive disease vs platinum-insensitive disease).

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

Arms: arm 1: Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00281957
Conditions: Recurrent Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-08-01; Completion date: 2011-01-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. arm 2: Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Interventions: intervention 1: sorafenib tosylate intervention 2: tipifarnib intervention 3: temsirolimus
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given IV

Protocol documents: