Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066274
• Other study ID #: Accord 08
• Secondary ID: FRE-FNCLCC-ACCOR
• Status: Completed
• Phase: Phase 2
• Start date: July 23, 2002
• Est. completion date: April 1, 2007

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 1, 2007
• Est. primary completion date: November 4, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• FOLFIRI regimen

• FOLFOX regimen

• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Hospitalier de L' Agglomeration Montargoise	Amilly
France	Pole Sante Sarthe et Loir Hopital Pierre Daguet	Angers
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Clinique Sainte-Marguerite	Hyeres
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Centre Oscar Lambret	Lille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Polyclinique Francheville	Perigueux
France	Centre Eugene Marquis	Rennes
France	CHG Roanne	Roanne
France	Centre Hospitalier de Rodez	Rodez
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier Regional Metz Thionville	Thionville
France	Centre Hospitalier General Lucien Hussel	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Bécouarn Y, Senesse P, Thézenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficac — View Citation