Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer - Full Text View

Sponsor:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066274

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Irinotecan U 101440E Irinotecan hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2002

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066274

Locations

France
Centre Hospitalier de L' Agglomeration Montargoise
Amilly, France, 45207
Pole Sante Sarthe et Loir Hopital Pierre Daguet
Angers, France, 49036
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Clinique Sainte-Marguerite
Hyeres, France, 83400
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Centre Oscar Lambret
Lille, France, 59020
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
Polyclinique Francheville
Perigueux, France, 24004
Centre Eugene Marquis
Rennes, France, 35062
CHG Roanne
Roanne, France, F-42300
Centre Hospitalier de Rodez
Rodez, France, 12027
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Hospitalier Regional Metz Thionville
Thionville, France, 57126
Centre Hospitalier General Lucien Hussel
Vienne, France, 38200

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Yves Becouarn, MD

Institut Bergonié

More Information

Publications:

Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob J, Cvitkovic F, Montoto-Grillot C, Ychou M. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Sep 4; [Epub ahead of print]

Becouarn Y, Ychou M, Boucher E, et al.: A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (CPT-11 + oxaliplatin [IRINOX]) and two standard arms (LV5-FU2 + CPT-11 [FOLFIRI], LV5-FU2 + oxaliplatin [FOLFOX] in first line metastatic colorectal cancer (MCRC) (FNCLCC Accord 08). [Abstract] J Clin Oncol 24 (Suppl 18): A-3586, 2006.

ClinicalTrials.gov Identifier:	NCT00066274 History of Changes
Other Study ID Numbers:	CDR0000315384, FRE-FNCLCC-ACCORD-08/0103, EU-20233
Study First Received:	August 6, 2003
Last Updated:	January 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer
stage IV rectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Camptothecin

Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012