Status:
COMPLETED
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer
Lead Sponsor:
University of Rochester
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the safety of neoadjuvant and adjuvant sargramostim (GM-CSF) and adjuvant chemotherapy in patients with resectable stage II or III colon cancer. * Determine the effic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00262808
Start Date
March 1 2004
End Date
September 1 2006
Last Update
October 16 2013
Active Locations (2)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
2
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710