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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066274
First received: August 6, 2003
Last updated: January 10, 2009
Last verified: May 2005
  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 2

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:


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
UNICANCER
Investigators
Study Chair: Yves Becouarn, MD Institut Bergonié
  More Information

Publications:
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 April 21, 2014