Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00303771
First received: March 15, 2006
Last updated: March 3, 2014
Last verified: December 2006
  Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.

PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • survie sans progression [ Time Frame: 2011 ] [ Designated as safety issue: No ]
    survie sans progression


Secondary Outcome Measures:
  • survie globale [ Time Frame: 2011 ] [ Designated as safety issue: No ]
    survie globale


Enrollment: 282
Study Start Date: June 2003
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LV5FU2 classique
LV5FU2 classique
Drug: fluorouracil Drug: leucovorin calcium
Experimental: LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan
Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium
Active Comparator: LV5FU2 simplifié
LV5FU2 simplifié
Drug: fluorouracil Drug: leucovorin calcium
Experimental: LV5FU2 simplifié+ irinotécan
LV5FU2 simplifié + irinotécan
Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium

Detailed Description:

OBJECTIVES:

Primary

  • Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.

Secondary

  • Compare the tumor response rate and overall 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, prospective study. Patients are stratified according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%), associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80 years), alkaline phosphatase level (≤ 2 times normal vs > 2 times normal), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
  • Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 2.
  • Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and irinotecan hydrochloride IV over 90 minutes on day 1.
  • Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and irinotecan hydrochloride as in arm III.

In all arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Patients undergo surgery within 3-10 weeks after completing chemotherapy.

Quality of life is assessed at baseline and then every 2 months thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum

    • Metastatic disease
    • Unresectable disease
  • Measurable disease that is outside the field of prior irradiation
  • No brain metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Transaminases ≤ 5 times normal
  • Bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)
  • Creatinine clearance > 45 mL/min
  • Life expectancy > 3 months
  • No psychological, social, or geographical situation that would preclude study treatment
  • No chronic diarrhea or enteropathy
  • No coronary insufficiency or symptomatic cardiac disease
  • No other malignancy unless curatively treated
  • No contraindication to chemotherapy

PRIOR CONCURRENT THERAPY:

  • At least 6 months since prior adjuvant chemotherapy for the primary tumor
  • No prior extensive resection
  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303771

  Show 77 Study Locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Emmanuel Mitry, MD, PhD Hopital Ambroise Pare
  More Information

Additional Information:
Publications:
Mitry E, Phelip JM, Bonnetain F, et al.: Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-281, 2008.

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00303771     History of Changes
Other Study ID Numbers: CDR0000453855, FFCD-2001-02, EU-20546, AVENTIS-FFCD-2001-02, PFIZER-FFCD-2001-02
Study First Received: March 15, 2006
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the rectum
stage IV rectal cancer
stage IV colon cancer
adenocarcinoma of the colon
recurrent colon cancer
recurrent 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
Irinotecan
Fluorouracil
Levoleucovorin
Leucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on October 19, 2014