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

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Carcinoma of the Appendix; Colorectal Cancer

Treatments: Drug: thalidomide; Procedure: surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00310076

CCCWFU-BG02-406

CCCWFU-59202

CDR0000466311

CELGENE-CCCWFU-59202

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Chemo therapy followed by thalidomide

Experimental group

Description:

After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

Treatment:

Drug: thalidomide

Procedure: surgery