NCT00310076

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 .

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 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.

Conditions

• Carcinoma of the Appendix
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	thalidomide	Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
PROCEDURE	surgery	Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Timeline

• Start date: 2002-10-01
• Primary completion: 2011-07-01
• Completion: 2012-09-01
• First posted: 2006-04-03
• Last updated: 2018-08-23
• Results posted: 2012-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study