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Sponsored by: |
Theradex |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024401 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: DHA-paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum |
Study Start Date: | May 2001 |
OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study treatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-50 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: Histologically or cytologically confirmed cancer of the colon or rectum Clinical evidence of metastatic disease Failed 1 prior chemotherapy regimen for metastatic disease Measurable disease No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease No prior taxanes At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy Surgery: At least 14 days since prior major surgery and recovered
United States, Arizona | |
Arizona Oncology Associates | |
Tucson, Arizona, United States, 85712-2254 | |
United States, District of Columbia | |
Veterans Affairs Medical Center - Washington, DC | |
Washington, District of Columbia, United States, 20422 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Kentucky | |
Albert B. Chandler Medical Center, University of Kentucky | |
Lexington, Kentucky, United States, 40536-0084 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, New Jersey | |
Veterans Affairs Medical Center - East Orange | |
East Orange, New Jersey, United States, 07018-1095 |
Study Chair: | Ross C. Donehower, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000068929, THERADEX-P01-00-01, ABCCC-010505, PROTARGA-P01-00-01 |
Study First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024401 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Antimitotic Agents Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Digestive System Diseases Rectal Cancer Paclitaxel Tubulin Modulators Neoplasm Metastasis Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Mitosis Modulators Colonic Diseases Antimitotic Agents Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |