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DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer. DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer  DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,stage 4 colon cancer,recurrent rectal cancer,Stage 4 rectal cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RossDonehower, Study Chair, Theradex
Arizona Oncology Associates
Tucson, Arizona, 85712-2254
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Additional Information:
Study ID Numbers: CDR0000068929; ABCCC-010505,THERADEX-P01-00-01,PROTARGA-P01-00-01
Study Start Date: May 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024401
Other Stage 4 Rectal Cancer Studies:
1. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
3. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
4. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
5. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other New Jersey Clinical Trials
Other East Orange Clinical Trials
DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
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