Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Progression Free Survival [ Time Frame: 60 months after treatment ]

Original Primary Outcome:

Current Secondary Outcome: Toxicity [ Time Frame: 24 months ]

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: March 29, 2006
Date Started: October 2002
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017