Phase
Condition
Colorectal Cancer
Colon Cancer; Rectal Cancer
Rectal Cancer
Treatment
N/AClinical Study ID
Ages 18-120 All Genders
Study Summary
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
Study Design
Study Description
Connect with a study center
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina 27157-1096
United StatesSite Not Available

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