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
Condition: Carcinoma of the Appendix; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: thalidomide; surgery
Intervention description: Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.; Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
Intervention MeSH terms: Thalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: carcinoma of the appendix; stage II colon cancer; stage III colon cancer; stage IV colon cancer; recurrent colon cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer

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 .
    

Eligibility 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