ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00117156
Conditions: Lymphoma, Non-Hodgkin MALT Lymphoma
Keywords: Fludarabine Rituximab Marginal Zone Lymphoma MALT lymphoma
Sponsor: Dana-Farber Cancer Institute
Start date: 2003-12-01; Completion date: 2012-01-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.

Detailed description:
Objectives:

Primary

\- To estimate the objective response rate.

Secondary

* To assess the safety.
* To describe the progression-free survival at one year.
* To examine the association between clonal cytogenetic abnormalities identified by FISH, and the objective response rate as well as the progression-free survival at one year.

Target enrollment was 30 eligible patients. An 80% objective response rate at 1 month restaging after 6 cycles was considered as evidence of activity in this patient population while 60% was not considered activity. If at least 22 patients achieved objective response the treatment would be considered promising. With 30 eligible patients, the probability of observing this was 0.87 assuming a true rate of 80% and 0.09 assuming a true rate of 60%.

Arms: arm 1: Fludarabine:

25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles

Rituximab:

375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts \> 10x10\^9/L

Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
Interventions: intervention 1: Fludarabine intervention 2: Rituximab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00242567
Conditions: Prostate Cancer
Keywords: zoledronic acid bone metastases prostate cancer hormone-sensitive
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-01; Completion date: 2012-01-01
Enrollment: 522 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment

Detailed description:

Arms: arm 1: Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. arm 2: Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level.
Interventions: intervention 1: Zoledronic Acid intervention 2: Androgen Deprivation Therapy (ADT)
Intervention descriptions: intervention 1: Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.

After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.

The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes. intervention 2: Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.

Protocol documents:
Clinical trial NCT00265317
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small cell lung cancer sunitinib erlotinib Phase 2
Sponsor: Pfizer
Start date: 2006-06-01; Completion date: 2012-01-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: erlotinib intervention 2: sunitinib intervention 3: erlotinib intervention 4: placebo
Intervention descriptions: intervention 1: erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity intervention 2: Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity intervention 3: erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity intervention 4: Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00282087
Conditions: Leiomyosarcoma Uterine Neoplasm
Keywords: early stage high grade uterine leiomyosarcoma adjuvant treatment
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2006-01-01; Completion date: 2012-01-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Detailed description:
Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Arms: arm 1: Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access).
Interventions: intervention 1: gemcitabine, docetaxel, doxorubicin
Intervention descriptions: intervention 1: Cycles = 28 days

Protocol documents:
Clinical trial NCT00307294
Conditions: Prostate Cancer
Keywords: Prostate Androgen AIPC Doxil
Sponsor: University of Pittsburgh
Start date: 2006-03-01; Completion date: 2012-01-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

Detailed description:
This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen independent prostate cancer whom have a rising PSA while on chemotherapy. The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease (If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate overall survival for this combination. There will be between 18 and 35 subjects at least 18 years of age enrolled on this single site study.

Arms: arm 1: Combination of Thalidomide and Doxil
Interventions: intervention 1: Thalidomide intervention 2: Doxil
Intervention descriptions: intervention 1: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg intervention 2: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Protocol documents:
Clinical trial NCT00359021
Conditions: HIV-1
Keywords: HIV-1 treatment experienced virologic failure
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2006-06-01; Completion date: 2012-01-01
Enrollment: 503 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

Detailed description:
This is a Phase III open-label, roll-over trial to evaluate the long term tolerability, safety, antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy including TMC114/rtv in HIV-1 infected patients who participated in one of the DUET (TMC125-C206 or TMC125-C216) trials. Also the change in HIV-1 resistance over time will be evaluated. This trial offers patients meeting the definition of virologic failure at Week 24 or beyond the option to roll-over to an open-label trial where they will receive TMC125 and TMC114/rtv. Three hundred patients are estimated to enroll into this trial. The withdrawal visit of the DUET trial will be the first visit of this trial. From this visit onward, all patients will receive 200 mg twice daily TMC125 and 600/100 mg twice daily TMC114/rtv until both TMC114 and TMC125 are commercially available or the therapy is no longer of clinical benefit to the patient. Patients will receive an antiretroviral therapy consisting of TMC125 as the only non-nucleoside reverse transcriptase inhibitor (NNRTI), TMC114/rtv as the only protease inhibitor (PI) and an optimized background, which will be selected by the investigator according to the local standard of care, the patient's experience with previous therapies and most recent resistance testing. The most recent HIV-1 genotype-analysis system report results from the DUET trial will be made available. TMC125 will be dosed at 200 mg twice daily, administered orally as 2 tablets twice daily with food.TMC114/rtv will be dosed at 600/100 mg twice daily, administered orally as 2 tablets TMC114 and 1 capsule ritonavir twice daily with food.The optimized background will comprise of at least 1 approved ARV drug: 1 or more NRTI(s), with or without ENF. Administration will continue until both TMC114 and TMC125 are commercially available or therapy is no longer of clinical benefit to the patient.

Arms: arm 1: TMC125 200 mg twice daily until commercially available
Interventions: intervention 1: TMC125
Intervention descriptions: intervention 1: 200 mg twice daily until commercially available

Protocol documents:
Clinical trial NCT00368459
Conditions: Alzheimer Disease
Keywords: raloxifene, women
Sponsor: Stanford University
Start date: 2006-08-01; Completion date: 2012-01-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multisite pilot randomized trial of raloxifene or placebo for the treatment of women with Alzheimer's disease.

Detailed description:
Raloxifene , a selective estrogen receptor modulator, has attracted attention as a potential treatment for Alzheimer's disease in women, but it has not been studied in this disorder.

To assess feasibility of large-scale efficacy trials and to obtain an initial estimate of treatment effect, study investigators plan to conduct a pilot, randomized, double blind, placebo-controlled, clinical trial of high-dose (120 mg daily) raloxifene. Eligible participants are postmenopausal women with late-onset Alzheimer's disease of mild-to-moderate severity taking a stable dose of an approved cholinesterase inhibitor. This pilot study is not designed to have power to detect significant, modest between-group differences of the magnitude provided by current FDA-approved therapies.

Study participants will be randomly allocated to oral raloxifene or identical placebo over a 12 month period. Outcomes of interest will be obtained at 6 and 12 months. The prespecified primary outcome is the change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog), compared between groups at 12 months. Prespecified secondary outcomes include measures of global severity (Clinical Dementia Rating sum of boxes), function (Activities of Daily Living), behavior (Neuropsychiatric inventory), and other neuropsychological measures. Caregiver outcomes will be burden (Zarit burden inventory) and distress (from the Neuropsychiatric inventory).

Arms: arm 1: oral raloxifene 120 mg once daily arm 2: identical appearing oral placebo
Interventions: intervention 1: raloxifene intervention 2: Placebo
Intervention descriptions: intervention 1: Raloxifene is a selective estrogen receptor modulator intervention 2: Identical appearing placebo

Protocol documents:
Clinical trial NCT00379145
Conditions: Sarcoma
Keywords: uterine leiomyosarcoma recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma
Sponsor: Gynecologic Oncology Group
Start date: 2007-06-01; Completion date: 2012-01-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as trabectedin, 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 trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.

Detailed description:
OBJECTIVES:

* Determine the antitumor activity of trabectedin, as measured by frequency and duration of objective response, in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
* Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Arms: arm 1: Trabectedin IV over 24 hours every 3 weeks
Interventions: intervention 1: trabectedin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00388037
Conditions: Recurrent Fallopian Tube Cancer Recurrent Ovarian Epithelial Cancer Recurrent Primary Peritoneal Cavity Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIA Primary Peritoneal Cavity Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIB Primary Peritoneal Cavity Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Epithelial Cancer Stage IIIC Primary Peritoneal Cavity Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Epithelial Cancer Stage IV Primary Peritoneal Cavity Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-01-01; Completion date: 2012-01-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

III. To document cancer antigen 125 (CA125) response rate, early objective progression rate, and, if objective responses are observed, response duration.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) 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 up at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00390416
Conditions: Stomach Neoplasms Esophageal Neoplasms
Keywords: Metastatic Gastroesophageal Docetaxel Cisplatin Fluorouracil Bevacizumab Metastatic Gastroesophageal Adenocarcinoma 06-096
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-10-01; Completion date: 2012-01-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to find out what effects a drug named/called bevacizumab has on patients and patients' tumors when given together with standard chemotherapy drugs. Making new blood vessels seems to be important for many tumors to grow. Bevacizumab is a new type of treatment for cancer that blocks the growth of new tumor blood vessels. In this study, the researchers will combine bevacizumab with chemotherapy drugs that are standard for the patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin. The way the original combination of cisplatin, docetaxel, and fluorouracil was given caused many side effects including gastrointestinal symptoms, weakness, and a drop in the blood count of infection fighting cells. For this study, the researchers have modified this combination to give lower doses of the medicines more often, to reduce side effects from the chemotherapy. Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and fluorouracil. This study is called a phase II study. In this study, everyone will have similar tumors and receive the same treatment.

Detailed description:

Arms: arm 1: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Interventions: intervention 1: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Intervention descriptions: intervention 1: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes

Protocol documents:
Clinical trial NCT00392444
Conditions: Advanced Malignant Mesothelioma Recurrent Malignant Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-02-01; Completion date: 2012-01-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Assess the efficacy of sunitinib malate, in terms of response rate (complete and partial), in patients with malignant pleural mesothelioma.

II. Assess the toxicity, safety, and tolerability of this drug in these patients.

III. Assess the duration of response or stable disease, stable disease rate, progression-free survival, and median and overall survival rates.

OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00392496
Conditions: Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-02-01; Completion date: 2012-01-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory diffuse or mediastinal large B-cell lymphoma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the response rate in patients with relapsed or refractory, diffuse or mediastinal, large B-cell lymphoma treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the effects of this drug on peripheral blood biomarkers, circulating endothelial cells, and their precursors in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Arms: arm 1: This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Given orally

Protocol documents: