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NCT ID: NCT00072462 Completed - Breast Cancer Clinical Trials

Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

IBIS-II DCIS
Start date: September 2003
Phase: Phase 3
Study type: Interventional

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

NCT ID: NCT00069784 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

ORIGIN
Start date: August 2003
Phase: Phase 3
Study type: Interventional

The primary objectives of the ORIGIN study were: - To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes; - To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes. The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce: - total mortality (all causes); - the risk of diabetic microvascular outcomes; - the rate of progression of IGT or IFG to type 2 diabetes.

NCT ID: NCT00069121 Completed - Colorectal Cancer Clinical Trials

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

Start date: April 18, 2003
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

NCT ID: NCT00069095 Completed - Colorectal Cancer Clinical Trials

A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

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

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

NCT ID: NCT00068042 Completed - Acromegaly Clinical Trials

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

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

The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.

NCT ID: NCT00063726 Completed - Multiple Myeloma Clinical Trials

A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

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

The purpose of this study is to allow patients to receive VELCADEā„¢ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

NCT ID: NCT00057720 Completed - Ovarian Neoplasms Clinical Trials

TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

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

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

NCT ID: NCT00057564 Completed - Multiple Myeloma Clinical Trials

A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

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

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

NCT ID: NCT00056407 Completed - Neoplasms, Prostate Clinical Trials

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

REDUCE
Start date: March 2003
Phase: Phase 3
Study type: Interventional

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

NCT ID: NCT00051051 Completed - Breast Neoplasms Clinical Trials

A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer

Start date: December 2002
Phase: Phase 2
Study type: Interventional

CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).