Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer.

Further Study Information

OBJECTIVES:

• Compare the efficacy of fluorouracil and leucovorin calcium with or without oxaliplatin in prolonging disease-free survival and overall survival in patients with stage II or III carcinoma of the colon.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV (administered after 1 hour of leucovorin calcium) weekly for 6 weeks.

• Arm II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and leucovorin calcium and fluorouracil as in arm I.

Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 6, 9, and 12 months; every 6 months for 4 years; and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,472 patients will be accrued for this study within 3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Previously resected potentially curable stage II or III carcinoma of the colon (T3,4; N0,1,2; M0)

• Distal extent of tumor(s) at least 12 cm from anal verge on endoscopy

• No tumors demonstrating free perforation as manifested by free air or fluid in the abdomen (walled off perforations allowed)

• Adjacent structures (e.g., bladder, small intestine, ovary) involved with primary tumor must have been curatively resected

• No prior or concurrent colon tumors other than carcinoma (sarcoma, lymphoma, carcinoid)

• No prior invasive colon or rectal malignancy

• No primary tumors involving both colon and rectum

• No isolated, distant, or noncontiguous intraabdominal metastases, even if resected

• Intestinal obstruction allowed

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• At least 10 years (excluding cancer)

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• Alkaline phosphatase normal

• SGOT/SGPT normal

Renal:

• Creatinine normal

Cardiovascular:

• No active ischemic heart disease (New York Heart Association class III-IV)

• No myocardial infarction within the past 6 months

• No concurrent symptomatic arrhythmia

Other:

• No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix treated by resection only, or lobular carcinoma in situ of the breast

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No nonmalignant systemic disease that would preclude study entry

• No grade 2 or greater peripheral neuropathy

• No psychiatric or addictive disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic response modifiers

Chemotherapy:

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for this malignancy

• No concurrent radiotherapy for this malignancy

Surgery:

• See Disease Characteristics

• No more than 42 days since prior curative resection

• No prior noncurative surgical resection for this malignancy, except colostomy

• No prior laparoscopically assisted colectomy (unless participating in Intergroup Protocol INT 0146 or the Australasian ALCCaS protocol)

Other:

• No other concurrent investigational drugs

• No concurrent halogenated antiviral agents (e.g., sorivudine)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

J. Philip Kuebler

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00004931
Information obtained from ClinicalTrials.gov on May 06, 2012

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