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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer

Conditions
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Carcinoma of the Appendix, Colorectal Cancer

Intervention / Treatment
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* Drug: thalidomide
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemo therapy followed by thalidomide<br>After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. | Drug: thalidomide<br>* Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.<br>Procedure: surgery<br>* Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression | Time to progression after surgery was recorded. | 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 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 | up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II colon cancer, carcinoma of the appendix, 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