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NCT ID: NCT00085163 Completed - Colorectal Cancer Clinical Trials

Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon

Start date: March 2004
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon. PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

NCT ID: NCT00083304 Completed - Breast Cancer Clinical Trials

Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

ENRICH
Start date: February 2004
Phase: Phase 3
Study type: Interventional

RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

NCT ID: NCT00082433 Completed - Breast Cancer Clinical Trials

Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Start date: November 2003
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

NCT ID: NCT00081796 Completed - Breast Cancer Clinical Trials

Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

Start date: April 2004
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

NCT ID: NCT00081588 Completed - HIV Infection Clinical Trials

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

Start date: November 2003
Phase: Phase 2
Study type: Interventional

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

NCT ID: NCT00078338 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Start date: February 16, 2004
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

NCT ID: NCT00077805 Completed - Clinical trials for Acute Ischemic Stroke

PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

Start date: August 2003
Phase: Phase 4
Study type: Interventional

Primary objective: - To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke. Secondary objectives: - To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization - To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization - To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke

NCT ID: NCT00077792 Completed - Clinical trials for Myocardial Infarction

Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

Start date: October 2002
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

NCT ID: NCT00077766 Completed - Anemia Clinical Trials

A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

Start date: March 2004
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

NCT ID: NCT00077753 Completed - Clinical trials for Venous Thromboembolism

EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

Start date: February 2002
Phase: Phase 4
Study type: Interventional

Primary objective: - To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: - To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis - To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study - To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: - Major and minor hemorrhage - Heparin induced thrombocytopenia - Serious adverse events - To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.