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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFIRI regimen
FOLFOX regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier de L' Agglomeration Montargoise
  • Pole Sante Sarthe et Loir Hopital Pierre Daguet
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Clinique Sainte-Marguerite
  • Centre Hospitalier Departemental
  • Centre Oscar Lambret
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Antoine Lacassagne
  • CHR D'Orleans - Hopital de la Source
  • Polyclinique Francheville
  • Centre Eugene Marquis
  • CHG Roanne
  • Centre Hospitalier de Rodez
  • Centre Rene Huguenin
  • Centre Hospitalier Regional Metz Thionville
  • Centre Hospitalier General Lucien Hussel

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 6, 2003
Last Updated
February 25, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00066274
Brief Title
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 23, 2002 (Actual)
Primary Completion Date
November 4, 2005 (Actual)
Study Completion Date
April 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Becouarn, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier de L' Agglomeration Montargoise
City
Amilly
ZIP/Postal Code
45207
Country
France
Facility Name
Pole Sante Sarthe et Loir Hopital Pierre Daguet
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Clinique Sainte-Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Polyclinique Francheville
City
Perigueux
ZIP/Postal Code
24004
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35062
Country
France
Facility Name
CHG Roanne
City
Roanne
ZIP/Postal Code
F-42300
Country
France
Facility Name
Centre Hospitalier de Rodez
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Centre Hospitalier General Lucien Hussel
City
Vienne
ZIP/Postal Code
38200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17785765
Citation
Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. 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 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4.
Results Reference
result

Learn more about this trial

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

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