RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer .
OBJECTIVES: Primary * Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant thalidomide. Secondary * Estimate progression-free survival probability of patients treated with this regimen. * Obtain toxicity data for patients receiving long-term oral thalidomide therapy. OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Time to Progression
Time to progression after surgery was recorded.
Time frame: 9 hours
Progression Free Survival
Time frame: 60 months after treatment
Number of Events of Toxicity Graded 3 and 4
Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported
Time frame: up to 60 months
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