Status:
COMPLETED
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
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Carcinoma of the Appendix
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 phas...
Detailed Description
OBJECTIVES: Primary * Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00310076
Start Date
October 1 2002
End Date
September 1 2012
Last Update
August 23 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096