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: September 19, 2013
Last verified: November 2005

November 1, 1999
September 19, 2013
November 1991
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Complete list of historical versions of study NCT00003063 on ClinicalTrials.gov Archive Site
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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Adjuvant Chemoimmunotherapy for Colorectal Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: recombinant interferon alfa
  • Drug: fluorouracil
  • Drug: leucovorin calcium
  • Drug: levamisole hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1050
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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
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Italy,   Korea, Republic of
 
NCT00003063
CDR0000065728, CNR-TONE-01, EU-97011
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European Institute of Oncology
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Study Chair: Francesco Tonelli, MD Universita Degli Studi di Florence - Policlinico di Careggi
National Cancer Institute (NCI)
November 2005

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