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
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|ClinicalTrials.gov Identifier: NCT00310076|
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : August 28, 2012
Last Update Posted : August 23, 2018
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 .
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of the Appendix Colorectal Cancer||Drug: thalidomide Procedure: surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||September 2012|
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.
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
- Time to Progression [ Time Frame: 9 hours ]Time to progression after surgery was recorded.
- Progression Free Survival [ Time Frame: 60 months after treatment ]
- Number of Events of Toxicity Graded 3 and 4 [ Time Frame: up to 60 months ]Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310076
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Perry Shen, MD||Wake Forest University Health Sciences|