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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077259 |
RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: epothilone D |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC) |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-69 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000350080, MSKCC-03113, ROCHE-NO17320 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077259 |
Health Authority: | United States: Federal Government |
recurrent colon cancer recurrent rectal cancer stage III colon cancer stage III rectal cancer |
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Epothilones Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |