Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer
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Keep this study
Lead
Wake Forest University Health Sciences
With
National Cancer Institute (NCI)
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer
* Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks
* Patients with residual disease or no evidence of disease after IPHC are eligible
No extra-abdominal disease or parenchymal liver metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-3
Free of infection or postoperative complications
Hemoglobin \> 8.0 g/dL
Absolute neutrophil count \> 1,000/mm³
Platelet count \> 100,000/mm³
PTT or PT \< 1.5 times normal (except in patients who are receiving therapeutic anticoagulant therapy for non-related medical conditions, such as atrial fibrillation)
Bilirubin \< 1.5 mg/dL OR direct bilirubin ≤ 1.0 mg/dL (for patients with Gilbert's syndrome)
AST/ALT ≤ 2.5 times normal
Serum creatinine \< 2.0 mg/dL
No peripheral neuropathy \> grade 1, except localized neuropathy due to a mechanical cause or trauma
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception for 4 months prior to, during, and for 4 months after treatment with thalidomide
No history of hepatic cirrhosis
No history of severe hypothyroidism
No history of medical problem such as severe congestive heart failure or active ischemic heart disease
No other malignancy within the past 5 years except nonmelanoma skin cancer
No known history of deep vein thrombosis or pulmonary embolus
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior chemotherapy, biologic therapy, or radiotherapy (except for IPHC)
No other concurrent systemic therapy
No concurrent high level sedatives
No concurrent sedating "recreational" drugs or alcohol
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