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Home > "C" Clinical Trials Conditions > Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer  Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,Stage 4 rectal cancer
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy containing irinotecan and oxaliplatin with that of two standard combination chemotherapy regimens in treating patients who have unresectablemetastaticcolorectal cancer.
Details: OBJECTIVES: - Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer. - Compare the progression-free survival of patients treated with these regimens. - Compare the tolerability of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1. - Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. - Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months for 1 year. Patients are followed at 2 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal carcinoma - Metastatic disease - Not amenable to surgery - Unidimensionally measurable disease - No bone metastases - No brain metastases PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - WHO 0-2 Life expectancy - At least 12 weeks Hematopoietic - Neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present) - SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present) Renal - Creatinine no greater than 1.25 times ULN Cardiac - No concurrent cardiac abnormalities that would preclude study therapy Pulmonary - No concurrent pulmonary abnormalities that would preclude study therapy Other - Not pregnant or nursing - Fertile patients must use effective contraception - No chronic enteropathy - No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer - No concurrent severe uncontrolled infection - No obstruction or partial obstruction that would interfere with study therapy - No psychological, social, familial, or geographical situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer biological response modifiers Chemotherapy - No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago) - No prior irinotecan - No prior oxaliplatin - No other concurrent chemotherapy Endocrine therapy - No concurrent anticancer hormonal therapy Radiotherapy - At least 4 weeks since prior pelvic radiotherapy - No prior abdominopelvic radiotherapy Surgery - At least 4 weeks since prior surgery - No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines) Other - No other concurrent experimental medication - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
YvesBecouarn, Study Chair, Institut Bergonie
Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon, , F-85025
France
Recruiting Roger Faroux 33-02-5144-6168
Centre Hospitalier de Rodez *Recruiting*
Rodez, , 12027
France
Recruiting Alain Maare 33-05-6575-1760
Polyclinique de Francheville *Recruiting*
Perigueux, , 24004
France
Recruiting Laurent Cany 33-05-5306-4140
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Thierry Conroy 33-03-83-59-84-60
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Eric Francois 33-04-9203-1114
CHG Roanne *Recruiting*
Roanne, , F-42300
France
Recruiting M.C. Gouttebel 33-4-77-44-33-96
Pole Sante Sarthe et Loir Hopital Pierre Daguet *Recruiting*
Angers, , 49036
France
Recruiting Dominique Luet 33-2-4135-2700
CHR D'Orleans - Hopital de la Source *Recruiting*
Orleans, , 45100
France
Recruiting Jean-Paul Lagasse 33-02-3651-4704
Hopital Louis Pasteur *Recruiting*
Colmar, , 68021
France
Recruiting Jacques Goineau 33-03-8912-4097
Centre Eugene Marquis *Recruiting*
Rennes, , 35062
France
Recruiting Eveline Boucher 33-02-9925-3180
Centre Hospitalier General Lucien Hussel *Recruiting*
Vienne, , 38200
France
Recruiting Denis Pere-Verge 33-04-7431-3375
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92210
France
Recruiting Frederique Bertheault-Cvitkovic 33-01-47-111-515
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting J.H. Jacob 33-02-3145-5016
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Marc Ychou 33-04-67-613-066
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Yves Becouarn 33-5-56-333-242
Additional Information:
Study ID Numbers: CDR0000315384; EU-20233,FRE-FNCLCC-ACCORD-08/0103
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066274
Other Stage 4 Rectal Cancer Studies:
1. Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
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Other Angers Clinical Trials
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
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