Colon Cancer Clinical Trial
GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer
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.
Full 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 efficacy, in terms of enhanced tumor-associated macrophage response, of this regimen in these patients.
Secondary
Determine overall survival and time to progression in patients treated with this regimen.
OUTLINE:
Neoadjuvant therapy and surgery: Patients receive sargramostim (GM-CSF) subcutaneously (SC) once daily beginning between days -16 and -12 and continuing until day -1. Patients undergo surgical resection on day 0. Patients with stage I or IV disease are removed from the study. All other patients proceed to adjuvant chemotherapy or observation.
Adjuvant chemotherapy or observation: Patients with high-risk stage II or any stage III disease are assigned to group 1 or 2. Patients with low-risk stage II disease are assigned to group 3.
Group 1 (adjuvant therapy for high-risk stage II disease): Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV on days 1, 8, 15, 22, 29 and 36. Patients also receive GM-CSF SC once daily on days 50-54. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Group 2 (adjuvant therapy for stage III disease): Patients receive adjuvant chemotherapy and GM-CSF as in group 1. Alternatively, patients may receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. These patients also receive GM-CSF SC once daily on days 10-14 of every fourth course. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Group 3 (low-risk stage II disease): Patients undergo observation only every 3 months.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility 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
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There are 2 Locations for this study
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
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