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
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 .
Carcinoma of the Appendix
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer|
- Progression Free Survival [ Time Frame: 60 months after treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Study Completion Date:||September 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Chemo therapy followed by thalidomide
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.Procedure: surgery
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310076
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Perry Shen, MD||Comprehensive Cancer Center of Wake Forest University|