Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00091312

First received: September 7, 2004

Last updated: February 6, 2009

Last verified: December 2006

History of Changes

Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.

PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: adjuvant therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors

Resource links provided by NLM:

Drug Information available for: Fluorouracil Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Disease-free survival at 5 years

Secondary Outcome Measures:

Overall survival at 8 years
Tolerability
Correlation of clinical, histological, and biological prognostic factors with outcome


Estimated Enrollment:	1976
Study Start Date:	June 2004

Detailed Description:

OBJECTIVES:

Primary

Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy.

Secondary

Compare 8-year overall survival in patients treated with these regimens.
Compare tolerability of these regimens in these patients.
Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (pT3 vs pT4), pathological differentiation (poorly or undifferentiated vs well or moderately differentiated), and microsatellite instability (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens.
- Regimen A: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1, 15, and 29. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen B: Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
- Regimen C: Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients undergo observation only. Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 1,976 patients (988 per treatment arm [247 each in regimens A and B of arm I and 494 in regimen C of arm I]) will be accrued for this study within 4.5 years.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the colon
- Stage II disease (pT3, N0 or pT4, N0)
  - Penetration of the subserosa or serosa
  - No lymph node metastases
    - At least 12 lymph nodes analyzed
More than 1 synchronous primary colon tumor allowed
- Staging determined for the more advanced tumor
Curative radical resection within the past 2-8 weeks required
- Proximal, distal, and radical margins must be free of tumor (R0 resection)
No rectal tumors
- Gross distal margin of the primary tumor must lie above the peritoneal reflection
No known familial adenomatous polyposis
No hereditary nonpolyposis colorectal cancer
No distant metastases

PATIENT CHARACTERISTICS:

Age

18 to 75

Performance status

WHO 0-1

Life expectancy

Not specified

Hematopoietic

Granulocyte count ≥ 2,000/mm^3
Platelet count ≥ 100,000mm^3
Hemoglobin ≥ 10 g/dL

Hepatic

Bilirubin < 1.25 times upper limit of normal (ULN)
No known Gilbert's syndrome

Renal

Creatinine < 1.25 times ULN

Cardiovascular

No severe or uncontrolled coronary disease
No severe heart failure
No uncontrolled arterial hypertension
No myocardial infarction within the past year
No cerebral vascular accident within the past year
Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy* NOTE: *Aspirin is not considered proper anticoagulation

Gastrointestinal

No Gardner's syndrome
No Turcot's syndrome
No Crohn's disease
No ulcerative colitis

Other

No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
No other serious disease
No contraindication to any study drugs
No known allergy to leucovorin calcium
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for up to 6 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

See Disease Characteristics

Other

No other concurrent anticancer therapy
No concurrent vitamin supplements containing folic acid

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: NCT00091312

Locations


Egypt
National Cancer Institute - Cairo
Cairo, Egypt
France
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne Billancourt, France, F-92104
Hopital Du Bocage
Dijon, France, 21034
Germany
Medizinische Klinik I
Dresden, Germany, D-01307
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Azienda Ospedaliero Careggi
Florence, Italy, 50139
Universita Degli Studi di Florence - Policlinico di Careggi
Florence, Italy, 50139
Portugal
Instituto Portugues de Oncologia Centro do Porto, S. A.
Porto, Portugal, 4200-072
Spain
Hospital Universitario de Elche
Elche Alicante, Spain, E-03203

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Investigators


Study Chair:	Laurent Bedenne, MD	Hopital Du Bocage

More Information


ClinicalTrials.gov Identifier:	NCT00091312 History of Changes
Other Study ID Numbers:	CDR0000387797 FFCD-EORTC-40012 EORTC-40012 PETACC-4
Study First Received:	September 7, 2004
Last Updated:	February 6, 2009

Keywords provided by National Cancer Institute (NCI):


stage II colon cancer adenocarcinoma of the colon

Additional relevant MeSH terms:


Colorectal Neoplasms Colonic 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 Antineoplastic Agents, Phytogenic Antineoplastic 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 Protective Agents

ClinicalTrials.gov processed this record on June 23, 2017

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