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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer. Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer  Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic adenocarcinoma of the colon or rectum - Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) - Failure after first line therapy; Fluorouracil and leucovorin calcium OR Raltitrexed; No oxaliplatin or irinotecan - Relapse within 6 months of adjuvant therapy - Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis - No symptomatic brain metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: At least 2 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior surgery - Other: No other concurrent experimental drugs --Patient Characteristics-- - Age: 18 to 80 - Performance status: WHO 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 - Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN); Alkaline phosphatase no greater than 5 times ULN - Renal: Not specified - Other: No bowel obstruction; No other significant, uncontrolled underlying medical or psychiatric condition; No serious active infection; Neurologically stable; No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No psychological, social, familial, or geographical condition that would preclude study; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.Hebbar, Study Chair, GERCOR
Polyclinique De Courlancy
Reims, , F-51100
France
Clinique Saint Jean
Lyon, , 69008
France
Centre Hospital Universitaire Hop Huriez
Lille, , 59000
France
Clinique de l'Orangerie
Strasbourg, , 67010
France
Centre Jean Bernard
Le Mans, , 72000
France
C.H. Senlis
Senlis, , 60300
France
Intercommunal Hospital
Montfermeil, , 93370
France
CHU Pitie-Salpetriere
Paris, , 75651
France
Hopital Claude Gallien
Quincy-sous-Senart, , 91480
France
Centre Hospitalier de Mulhouse
Mulhouse, , 68051
France
Hopital Saint Antoine
Paris, , 75571
France
American Hospital of Paris
Neuilly-sur-Seine, , F-92202
France
Hopital Bichat-Claude Bernard
Paris, , 75018
France
Hopital Tenon
Paris, , 75970
France
Hopital Drevon
Dijon, , 21000
France
CH Meulan
Meulan, , 78250
France
Additional Information:
Study ID Numbers: CDR0000068128; FRE-GERCOR-C98-3-FIREFOX,EU-20023
Study Start Date: April 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006115
Other Recurrent Colon Cancer Studies:
1. Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
2. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
3. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
4. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Related Studies:
Other recurrent colon cancer Clinical Trials
Other Clinical Trials
Other Strasbourg Clinical Trials
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
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