ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00397488
Conditions: Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer
Keywords: recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder anterior urethral cancer posterior urethral cancer recurrent urethral cancer metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter urethral cancer associated with invasive bladder cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-09-01; Completion date: 2012-02-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
* Determine the safety of this regimen in these patients.

Secondary

* Determine the time to disease progression in patients treated with this regimen.

  * To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
  * To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Arms: arm 1: This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma. Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population. A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle. Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00409565
Conditions: Head and Neck Cancer Squamous Cell Carcinoma
Keywords: head and neck cancer cetuximab bevacizumab squamous cell carcinoma SCCHN Squamous Cell Carcinoma of the Head and Neck
Sponsor: National Cancer Institute (NCI)
Start date: 2006-09-01; Completion date: 2012-02-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination of two new drugs, cetuximab (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab is also approved by the FDA for the treatment of colorectal cancer

Detailed description:
Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States 1. Squamous cell carcinomas account for more than 90% of head and neck cancer cases. Patients with squamous cell carcinoma of the head and neck (HNSCC) usually present with locoregionally advanced disease. Initial presentation with distant metastasis may occur in about 10% of all patients. However, recurrence of disease either in local or distant sites after potentially curative treatment with surgery, radiation, and/or chemotherapy occurs in more than 50% of patients. Therefore, the majority of patients with HNSCC develop recurrent or metastatic disease during the course of their illness. These patients have a dismal prognosis with a median survival of 6-9 months 2-4.

Active single agents in head and neck squamous cell carcinoma include methotrexate, bleomycin, cisplatin, carboplatin, 5-FU, paclitaxel, docetaxel, and CPT-11. A small randomized study showed that cisplatin monotherapy prolongs survival compared with best supportive care 5. Response rates for single agents range between 10-40% 2, 4, 6, 7. Combination chemotherapy with platinum agents, in spite of achieving higher response rates (about 30% in phase III trials), has not been shown to produce a survival benefit compared to single agents in randomized comparisons in recurrent/metastatic head and neck cancer 2, 4.

Arms: arm 1: Cetuximab plus bevacizumab
Interventions: intervention 1: Cetuximab intervention 2: Bevacizumab
Intervention descriptions: intervention 1: * Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY
* Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations intervention 2: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given

Protocol documents:
Clinical trial NCT00424385
Conditions: Prostate Cancer
Keywords: AIPC, Prostate cancer prostate
Sponsor: Oncology Specialists, S.C.
Start date: 2007-01-01; Completion date: 2012-02-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached without toxicity, the study will close for accrual. If toxicity is noted prior to reaching the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design will be the one used for any future phase II study.

Detailed description:
Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer (AIPC) and the fact that both agents can be given orally with what appears to be tolerable side effects, we hypothesize that combining both agents may provide patients with another effective regimen in a disease where therapeutic options are limited. This study is designed to investigate the safety of combining Gleevec and Sorafenib as well as feasibility in AIPC patients who have failed one or more lines of systemic chemotherapy. Once safety is established, a follow-up phase II study will commence to investigate efficacy.

Arms: arm 1: Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
Interventions: intervention 1: Gleevec + Sorafenib
Intervention descriptions: intervention 1: 400 mg Sorafenib every day (QD) 300mg Gleevec QD

Protocol documents:
Clinical trial NCT00434109
Conditions: Neuroendocrine Tumor Islet Cell Tumor
Keywords: Carcinoid Pancreatic Metastatic Neuroendocrine Tumors Hepatic Artery Embolization Angiogenesis Sunitinib Malate Sutent Tyrosine Kinase Inhibitor
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-11-01; Completion date: 2012-02-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.

Detailed description:
This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.

Arms: arm 1: Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Interventions: intervention 1: Sunitinib malate intervention 2: Hepatic Artery Embolizations
Intervention descriptions: intervention 1: Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations. intervention 2: 1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.

Protocol documents:
Clinical trial NCT00453895
Conditions: Adrenocortical Carcinoma
Keywords: Adrenal cancer refractory to cytotoxic therapy Sunitinib Multitargeted tyrosine-kinase inhibitor
Sponsor: University of Wuerzburg
Start date: 2007-07-01; Completion date: 2012-02-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating patients urgently need a new treatment option. However, up to date there is no evidence for a single regimen that might be promising in these treatment-refractory patients with ACC.

Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities, which is successfully tested in the treatment of patients with metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after failure of standard cytotoxic chemotherapy.

The primary objective of this trial is to estimate the response (defined as progression-free survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC progressing after cytotoxic chemotherapy.

Detailed description:

Arms: arm 1: Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.

treatment will continue until progressive disease or unacceptable toxicity
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: 50mg Sunitinib

Protocol documents:
Clinical trial NCT00462280
Conditions: Precancerous Condition Stage 0 Melanoma Stage I Melanoma Stage II Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-05-01; Completion date: 2012-02-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the primary endpoint of the trial, by analysis of histopathologic regression of atypical nevi in response to a 6-month trial of oral (PO) lovastatin vs. placebo in subjects with atypical nevi.

SECONDARY OBJECTIVES:

I. To evaluate clinical regression of atypical nevi in the lovastatin vs. placebo group.

II. To evaluate the secondary endpoint of changes in nevi numbers on subjects' backs in the lovastatin vs. placebo groups.

III. To evaluate a number of molecular biomarkers as secondary endpoints in the lovastatin vs. placebo groups.

IV. To evaluate the correlation of serum markers known to be affected by lovastatin with the endpoints chosen above.

V. To evaluate the safety and tolerability of the dosing regimen, and the dose escalation.

OUTLINE: Patients are randomized into 1 of 2 treatment arms per group.

ARM I: Patients (with two matched nevi OR one large nevi) receive lovastatin PO once daily (QD) for up to 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients (with two matched nevi OR one large nevi) receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 weeks.

Arms: arm 1: Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. arm 2: Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity arm 3: Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity arm 4: Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: lovastatin intervention 2: placebo intervention 3: biopsy intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00483262
Conditions: Multiple Myeloma
Keywords: Temsirolimus Bortezomib
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-05-01; Completion date: 2012-02-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the safety of CCI-779 (Temsirolimus) and bortezomib (Velcade), and the highest dose of this drug that can be given to people safely. We will also be looking at how the combination of the two drugs may work against multiple myeloma. CCI-779 (Temsirolimus) is a drug that appears to stop myeloma cells from growing.

Detailed description:
* Since we are looking for the highest dose of CCI-779 (Temsirolimus) given in combination with bortezomib (Velcade) that can be given to people without causing the most serious or unmanageable side effects, not everyone who participates in this study will be receiving the same amount of either drug.
* During the study treatment, participants will be given some medications to decrease the chance they they will have an allergic reaction to CCI-779 (Temsirolimus). After these drugs are given, participants will be receive bortezomib (Velcade) by injection followed by an injection of CCI-779 (Temsirolimus). These drugs wil be given once a week for four weeks (on Days 1, 8, 15, and 22). On the fifth week (Day 29), participants will be given only CCI-779 along with the drugs to decrease the chance of an allergic reaction.
* The cycle will last 35 days and will occur twice before the doctor evaluates for response. The cycles will be repeated for up to 8 cycles as long as the participant does not have any severe or unmanageable side effects and the disease is responding to treatment.
* While receiving study treatment, participants will be seen at the clinic at the start of each cycle for the following: complete physical examination, blood work, urine collection, x-ray of bones (if study doctor deems necessary) and an electrocardiogram (prior to treatment and at the end of treatment)
* A bone skeletal survey will be performed at the end of treatment to measure the size of the participants tumors.
* After 8 cycles of treatment or if the participant has ended treatment, more tests will be performed. A physical exam, blood work, urine collection, skeletal survey, electrocardiogram, bone marrow biopsy and aspirate will be performed.

Arms: arm 1: In Phase I part, 15 or 25 mg temsirolimus (CCI-779)and 1·3 or 1·6 mg/m² bortezomib was given once a week.In Phase II, patients received intravenous temsirolimus once a week on days 1, 8, 15, 22, and 29 for a cycle of 35 days, and intravenous bortezomib once a week on days 1, 8, 15, and 22 for a cycle of 35 days, the MTD ascertained in the Phase I part.
Interventions: intervention 1: CCI-779 intervention 2: Bortezomib
Intervention descriptions: intervention 1: Given by injection once a week for 5 weeks (5 weeks equals one cycle) for up to 8 cycles intervention 2: Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles

Protocol documents:
Clinical trial NCT00492206
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: Non Small Cell Lung Cancer NSCLC EGFR Inhibitor Radiation Therapy
Sponsor: University of Pittsburgh
Start date: 2006-06-01; Completion date: 2012-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.

Detailed description:
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.

Arms: arm 1: Cetuximab 400 mg/m2 IV week 0 only

External beam radiation weeks 1 - 7

Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7

Cetuximab 250 mg/m2 IV weekly weeks 8 - 26

Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.

Protocol documents:
Clinical trial NCT00492336
Conditions: Schizophrenia
Keywords: Cognitive impairments Negative symptoms
Sponsor: University of Maryland, Baltimore
Start date: 2007-01-01; Completion date: 2012-02-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of a new medication for the treatment of cognitive impairments (thinking difficulties) and negative symptoms in people with schizophrenia. The new medication is rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration for the treatment of Parkinson's disease. It is used to treat cognitive problems.

Detailed description:
The study will consist of two phases: a 4-week continued stability phase (lead-in phase) and a 12-week double-blind treatment phase. In the lead-in phase, subjects receiving antipsychotic medication, who manifest moderate to severe and persistent negative symptoms, will remain on their maintenance regimen for at least four weeks. The treatment phase will be a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline (1 mg/day), a selective MAO-B oxidase inhibitor.

Arms: arm 1: Treatment with Rasagiline arm 2: Treatment with Placebo
Interventions: intervention 1: rasagiline (Pharmacodynamics) intervention 2: Placebo
Intervention descriptions: intervention 1: Rasagiline 1 mg/day for 12 weeks intervention 2: Placebo 1 tablet each day

Protocol documents:
Clinical trial NCT00506597
Conditions: Leukemia
Keywords: Acute Lymphoblastic Leukemia Leukemia Erwinia L-Asparaginase Erwinase
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-05-01; Completion date: 2012-02-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.

This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

Detailed description:
The Study Drug:

Erwinia L-Asparaginase helps stop the growth of cancer cells by blocking the nutrients that cancer cells needed to survive.

Study Visits:

Erwinia L-Asparaginase will be given either outpatient or inpatient, depending upon your condition.

If you are allergic to E. Coli Asparaginase or Pegylated Asparaginase, you will be given 6 doses every other day.

You will receive Erwinia L-Asparaginase as an injection through a needle in your vein, under the skin, or in your muscle, as directed by your study doctor.

You will be monitored closely by your nurse and your doctor before, during, and after receiving the drug for any side effects. If you develop a severe allergy to Erwinia L-Asparaginase, you may not receive any more asparaginase therapy.

The length of study will be based upon on the ALL treatment you are currently receiving. Your doctor will discuss the details of your treatment schedule with you.

This is an investigational study. Erwinia L-Asparaginase is not FDA approved. The FDA allows patients with acute lymphoblastic leukemia who have an allergic reaction to the U.S.-approved L-asparaginases to receive Erwinia L-Asparaginase. Up to 35 patients will take part in this study at The University of Texas (UT) MD Anderson Cancer Center.

Arms: arm 1: 6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
Interventions: intervention 1: Erwinase
Intervention descriptions: intervention 1: If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m\^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m\^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.

Protocol documents: