A PHASE II Study of GM-CSF As Pre- And Post-Operative Adjuvant Therapy For Stage II And III Colon Cancer
- 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.
- Determine overall survival and time to progression in patients treated with this
- 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
- 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
- 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
- Group 3 (low-risk stage II disease): Patients undergo observation only every 3
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with a change in tumor-associated macrophage VEGF expression
Alok A. Khorana, MD
James P. Wilmot Cancer Center
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|