ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00246753
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2005-10-01; Completion date: 2013-05-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the proportion of patients with hormone-refractory prostate cancer who experience \> 50% decline in prostate-specific antigen (PSA) after treatment with lapatinib ditosylate.

Secondary

* Determine the safety of this drug in these patients.
* Determine the time to PSA progression in patients treated with this drug.
* Determine the molecular correlates and predictive biomarkers of response in patients treated with this drug.

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

Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Serum samples are collected for biomarker analysis at baseline and every 4 weeks.

After completion of study treatment, patients are followed at 4 weeks.

Arms: arm 1: Single Arm Trial where each patient receives GW572016 (lapatinib ditosylate) at a dose of 1500mg daily initially until disease progression or unacceptable toxicity.
Interventions: intervention 1: lapatinib ditosylate
Intervention descriptions: intervention 1: 1500 mg, daily until disease progression

Protocol documents:
Clinical trial NCT00262834
Conditions: Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2013-05-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer.

OULINE: This is a multicenter, pilot study.

Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.

After completion of study treatment, patients are followed for 30 days.

Arms: arm 1: Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
Interventions: intervention 1: vorinostat intervention 2: conventional surgery
Intervention descriptions: intervention 1: Given orally, conventional surgery to follow. intervention 2: Undergo conventional surgery

Protocol documents:
Clinical trial NCT00330382
Conditions: Lip and Oral Cavity Cancer Oral Leukoplakia Oropharyngeal Cancer Tongue Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 1999-01-01; Completion date: 2013-05-01
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia

Detailed description:
PRIMARY OBJECTIVES:

I. Determine if chemoprevention by the Bowman-Birk inhibitor concentrate (BBIC) can prevent cancer in patients with oral leukoplakia (OL).

II. Determine the clinical and histologic response rate of OL to BBIC.

SECONDARY OBJECTIVES:

I. Measure the effect of BBIC on intermediate marker endpoint levels. II. Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity, erb-B2 (neu), retinioc acid receptor β, bcl-2, and mutant p53 expression, and serum levels of neu.

III. Determine the individual and group side effects of BBIC.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled, study. Prior to randomization, all patients receive oral placebo for 4 weeks. Patients who show good compliance (\> 75% packet count) are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires about diet, tobacco, and alcohol usage at baseline and at the completion of study treatment. Blood, urine, and biopsy tissue are collected at baseline and at the completion of study treatment. Oral mucosal cells are collected at baseline, during the run-in phase, at randomization, after completion of study treatment, and at 3 months after completion of study treatment. Samples are examined for protease activity, levels of bcl-2 and erbB-2, mutant p53 oncogene expression and epidermal growth factor receptor, and retinoic acid receptor-β expression.

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

Arms: arm 1: Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months arm 2: Patients receive oral placebo twice daily for 6 months
Interventions: intervention 1: Bowman-Birk inhibitor concentrate intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00379197
Conditions: Breast Cancer
Keywords: stage IV breast cancer, estrogen receptor positive recurrent breast cancer hormone-refractory, metastatic breast cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-07-01; Completion date: 2013-05-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Naltrexone may fight breast cancer by blocking the use of estrogen by the tumor cells. Naltrexone may also stop the growth of breast cancer by impairing blood flow to the tumor.

PURPOSE: This phase II trial is studying how well naltrexone works in treating women with metastatic breast cancer that is no longer responsive to previous hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of naltrexone in women with hormone-refractory, metastatic breast cancer as measured by serial fludeoxyglucose F 18 positron emission tomography-CT scans.

Secondary

* Determine the safety of naltrexone in these patients.
* Determine the median time to event (first time when maximum specific uptake values is higher than that at baseline) within 1 year of study entry.

OUTLINE: This is an open-label study.

Patients receive oral naltrexone once daily for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 weeks, patients may continue naltrexone off study at the discretion of the physician.

Patients undergo fludeoxyglucose F 18 positron emission tomography-CT scans at baseline, week 4, week 8, and periodically thereafter.

After completion of study treatment, patients are followed for up to 1 year.

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

Arms: arm 1: Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.
Interventions: intervention 1: naltrexone intervention 2: PET scan
Intervention descriptions: intervention 1: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. intervention 2: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-\[18F\]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up.

Protocol documents:
Clinical trial NCT00415909
Conditions: Chronic Myelogenous Leukemia
Keywords: Leukemia Chronic Myelogenous Leukemia CML Imatinib Gleevec TALL-104
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-12-01; Completion date: 2013-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

* To determine the response rate and duration of response with combination of TALL-104 cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia in chronic phase, that have not achieved, or have lost, adequate response to IM.
* To determine the toxicity of the combination of TALL-104 cells and IM therapy in this patient population.

Detailed description:
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for starting the type of leukemia patient has. TALL-104 cells are cells of the immune system that have been obtained from a patient with leukemia and then processed in the laboratory to try to make them able to kill leukemia cells.

If found to be eligible to take part in this study, patient will continue receiving imatinib mesylate by mouth at the same schedule and dose patient had been receiving before entering the study. Patient will receive TALL-104 cells through a needle in their vein over 1 hour on Days 1-4, and then again on Days 7, 10, 14, 17, and 21 of the cycle. The cycle will last 28 days.

Blood (about 1 tablespoon) will be drawn every week for the first 4 weeks, then every 2-4 weeks for 2 months, then every 4-6 weeks until 6 months, and then every 3-6 months for routine tests and to check for any effect on organs.

Patient will have follow-up visits at 1 month, 3 months, 6 months, and at least annually for 2 years, and then at least every 5 years from then on for the rest of your life. Blood (about 1 teaspoon) will be drawn to check the status of the disease. An additional 1 tablespoon will also be collected and stored to be analyzed in case unexpected side effects occur after receiving therapy. If patient experiences certain side effects, more blood may need to be drawn and more tests performed based on the side effects experienced.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: TALL-104 cells and imatinib mesylate (IM) therapy
Interventions: intervention 1: Imatinib Mesylate (IM) intervention 2: TALL-104 cells
Intervention descriptions: intervention 1: IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day. intervention 2: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells

Protocol documents:
Clinical trial NCT00430040
Conditions: Diabetes Mellitus, Type 2 Hypertension
Keywords: Type 2 Diabetes Mellitus Hypertension Carvedilol CR Beta-blocker Oxidative stress Inflammation Vascular benefits
Sponsor: University at Buffalo
Start date: 2007-02-01; Completion date: 2013-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.

Detailed description:
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function.

Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury.

This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone.

This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril with Carvedilol CR or lisinopril alone for 6 months and studying the effects of the drugs during this period and thereafter.

Arms: arm 1: carvedilol arm 2: lisinopril
Interventions: intervention 1: Carvedilol Controlled Release (CR) intervention 2: lisinopril
Intervention descriptions: intervention 1: lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study.

Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at least 2 weeks to achieve target blood pressure sSBP \<130 and sDBP \< 80 intervention 2: lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study

Protocol documents:
Clinical trial NCT00438100
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms Drug Therapy
Sponsor: Japan Breast Cancer Research Network
Start date: 2008-04-01; Completion date: 2013-05-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.

Detailed description:
The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with breast cancer in 2001, making it the leading cause of cancer among women since 1995. Statistical database in Exel format/outline of health welfare statistics from the Ministry of Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in 2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast cancer patients, detection and treatment at an earlier stage can lead to higher survival rates. However, the recurrence rate increases as the disease progresses. In addition, about thirty percent of all breast cancer patients are believed to have recurrent disease. Thus, developing treatments against recurrence may be an important task.

The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B recommendation) breast cancer. In a second-line therapy recommended for metastatic or recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is superior to docetaxel alone for improving survival. This regimen is recommended for patients with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation). However, data are lacking to support capecitabine as a standard regimen as a second-line therapy; its efficacy needs verification and further study. Accordingly, this study is designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride, to which an indication of "inoperable or recurrent breast cancer" was added, as a first-line therapy in patients with inoperable or recurrent breast cancer by comparing it with Capecitabine alone, which is already approved of the same indication.

Arms: arm 1: Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. arm 2: S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
Interventions: intervention 1: Capecitabine intervention 2: S-1
Intervention descriptions: intervention 1: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course. intervention 2: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.

Protocol documents:
Clinical trial NCT00459862
Conditions: Advanced Malignant Mesothelioma Localized Malignant Mesothelioma Recurrent Malignant Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-03-01; Completion date: 2013-05-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib 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. Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria.

II. Determine the clinical toxicities of this drug in this patient population.

SECONDARY OBJECTIVES:

I. Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria.

II. Determine the response rate in patients treated with this drug. III. Determine the effect of this drug on overall survival and time to progression in these patients.

IV. Assess predictive markers of activity of this drug in these patients. V. Assess serologic markers of target inhibition by this drug in these patients.

VI. Determine the clinical toxicities of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline and prior to each course of therapy and analyzed for markers of angiogenesis.

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

Arms: arm 1: Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: laboratory biomarker analysis intervention 2: pazopanib hydrochloride
Intervention descriptions: intervention 1: Correlative study intervention 2: Given orally

Protocol documents:
Clinical trial NCT00519077
Conditions: Head and Neck Neoplasms
Keywords: cancer squamous cell carcinoma head neck
Sponsor: University of Chicago
Start date: 2005-03-01; Completion date: 2013-05-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Detailed description:
This open-label, multi-institution, phase II study evaluated the activity of gefitinib at individually escalated doses up to 750mg to achieve the skin toxicity grade greater than or equal to 2. Patients were started on gefitinib 250mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose was escalated to 500 mg daily and again to 750 mg daily on next evaluation until grade 2 or greater skin toxicity was developed.

The protocol was later amended because of the reported lower efficacy of the 250 mg dose and patients were then started at 500 mg per day. There was no further dose escalation beyond 750 mg per day irrespective of the response or grade of skin toxicity. Therapy was discontinued upon disease progression, unacceptable toxicity, death or patient's withdrawal of consent. Dose interruptions were used as the first approach to managing the toxicity of the patients who experienced grade 3-4 non-hematological toxicities. Gefitinib was interrupted for up to a maximum of 14 days until the toxicities dropped to grade 1 or less. Adherence to therapy was monitored using drug diaries that were collected at each physician visit and assessed against pill counts.

Arms: arm 1: Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.

Protocol documents: