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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thalidomide

Criteria

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