GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon

• Stage II or III disease

• No carcinoma in situ

• No perforated or obstructed tumors

• No dual primary lesions by colonoscopy or barium enema

• Resectable disease

• Distal and proximal bowel end must be > 5 cm from tumor

• Tumor must not extend below peritoneal reflection

• No distant intra-abdominal metastases (even if resected)

• No rectal cancer

• No tumors that require opening of the pelvic peritoneum to define the extent of disease

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No uncontrolled cardiac arrhythmia

Immunologic

• No ongoing or active infection

• No allergy to yeast or yeast-based products

• No allergy to sargramostim (GM-CSF)

• No allergy to fluorouracil

• No allergy to leucovorin calcium

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of Crohn's disease

• No history of ulcerative colitis

• No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

• No psychiatric illness or social situation that would preclude study compliance

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy, including fluorouracil, for colon cancer

• No other concurrent chemotherapy

Radiotherapy

• No prior radiotherapy for colon cancer

• No concurrent radiotherapy

Other

• No other prior therapy for colon cancer

• No concurrent immunosuppressant therapy

• No other concurrent investigational agents

• No other concurrent anticancer therapy