DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00024401
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2001-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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DHA-paclitaxel
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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Ross C. Donehower, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Arizona Oncology Associates
Tucson, Arizona, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Countries
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Other Identifiers
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THERADEX-P01-00-01
Identifier Type: -
Identifier Source: secondary_id
ABCCC-010505
Identifier Type: -
Identifier Source: secondary_id
PROTARGA-P01-00-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000068929
Identifier Type: -
Identifier Source: org_study_id