Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003063

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: November 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 1991

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

Official Title ^ICMJE

Adjuvant Chemoimmunotherapy for Colorectal Cancer

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.

Detailed Description

OBJECTIVES:

Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.

OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.

Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.

Patients are followed every 3 months for 2 years, then every 6 months.

PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Biological: recombinant interferon alfa
Drug: fluorouracil
Drug: leucovorin calcium
Drug: levamisole hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

1050

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer
No evidence of residual disease after surgery
Tumor located above peritoneal reflection
No distant metastases

PATIENT CHARACTERISTICS:

Age:

75 and under

Performance status:

WHO 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 2.0 mg/dL
SGPT less than 2 times upper limit of normal

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No serious cardiac ischemia

Other:

Adequate metabolic functions
No prior neoplasm
No prior/concurrent illness
No insulin-dependent diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior immunotherapy for the current cancer

Chemotherapy

No prior chemotherapy for the current cancer

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for the current cancer

Surgery

Not specified

Gender

Both

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Greece, Italy, Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00003063

Other Study ID Numbers ^ICMJE

CDR0000065728, CNR-TONE-01, EU-97011

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

European Institute of Oncology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Francesco Tonelli, MD

Universita Degli Studi di Florence - Policlinico di Careggi

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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