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Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer Clinical research trials and Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer  Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
For Condition: adenocarcinoma of the rectum,Stage 4 rectal cancer,recurrent colon cancer,stage 4 colon cancer,recurrent rectal cancer,adenocarcinoma of the colon
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and leucovorin with irinotecan in treating patients who have recurrent or refractorymetastaticunresectablecolorectal cancer.
Details: OBJECTIVES: Primary - Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan. Secondary - Determine the objective response and stabilization rate in patients treated with this regimen. - Determine the time to treatment failure in patients treated with this regimen. - Determine the duration of response in patients treated with this regimen. - Determine overall survival rate in patients treated with this regimen. - Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal adenocarcinoma - Metastatic, unresectable disease - Meets 1 of the following criteria: - At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan - Evaluable disease - Evidence of disease (e.g., ascites or bone metastases) by imaging techniques - Progressive disease as defined by 1 of the following criteria: - Progressive disease while receiving first-line chemotherapy - Recurrent disease within 6 months after completing adjuvant chemotherapy - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin < 1.5 times upper limit of normal (ULN) - Alkaline phosphatase < 3 times ULN Renal - Not specified Cardiovascular - No uncontrolled angina - No myocardial infarction within the past 6 months Gastrointestinal - No chronic diarrhea grade 2 or greater - No unresolved fully or partially obstructed intestine Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other underlying disease or medical condition that would preclude study participation - No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix - No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior irinotecan Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - At least 3 weeks since prior surgery Other - No other concurrent clinical trial participation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MayMabro, , Centre Medico-Chirurgical Foch
Polyclinique De Courlancy *Recruiting*
Reims, , F-51100
France
Recruiting Philippe Colin 33-3-2684-0284
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Thierry Andre 33-1-6177-0708
Clinique Armoricaine De Radiologie *Recruiting*
Saint Brieux, , F-22015
France
Recruiting Pierre-Luc Etienne 33-2-9675-2222
American Hospital of Paris *Recruiting*
Neuilly-sur-Seine, , F-92202
France
Recruiting Bertrand Callet 33-1-4641-2525
Hopital Europeen Georges Pompidou *Recruiting*
Paris, , 75015
France
Recruiting Bruno Landi 33-1-5609-3555
Hopital Saint Antoine *Recruiting*
Paris, , 75571
France
Recruiting Aimery Gramont 33-1-49-282-336
Centre Hospital Universitaire Hop Huriez *Recruiting*
Lille, , 59037
France
Recruiting Mohamed Hebbar 33-3-2044-5479
Intercommunal Hospital *Recruiting*
Montfermeil, , 93370
France
Recruiting Mostefa Bennamoun 33-1-4850-1808
Centre Medico-Chirurgical Foch *Recruiting*
Suresnes, , 92151
France
Recruiting May Mabro 33-1-4625-2168
Clinique Saint Jean *Recruiting*
Lyon, , 69008
France
Recruiting Gerard Gledo 33-4-7878-1010
Clinique Ste - Marie *Recruiting*
Pontoise, , 95300
France
Recruiting Marie-Helene Filippi 33-01-3038-5805
Hopital Saint Joseph *Recruiting*
Marseille, , 13008
France
Recruiting Claude Bressac 33-4-9180-8211
Hopital Drevon *Recruiting*
Dijon, , 21000
France
Recruiting Michel Flesch 33-380-364-822
Clinique de l'Orangerie *Recruiting*
Strasbourg, , 67010
France
Recruiting Emmanuel Achille 33-3-8856-7300
Hopital Bichat - Claude Bernard *Recruiting*
Paris, , 75018
France
Recruiting Thomas Aparicio 33-01-4025-7000
Additional Information:
Study ID Numbers: CDR0000347378; FRE-GERCOR-FOLFIRI3-C00-2,EU-20333
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075595
Other Recurrent Rectal Cancer Studies:
1. Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
5. Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
Related Studies:
Other recurrent rectal cancer Clinical Trials
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Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
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