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 2

Completed

• Conditions: Carcinoma of the Appendix; Colorectal Cancer
• Interventions: Drug: thalidomide; Procedure: surgery

• Registration Number: NCT00310076
• Lead Sponsor: Wake Forest University Health Sciences

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 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.

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-29
• Study First Posted: 2006-04-03
• Primary Completion: 2011-07
• Results First Submitted: 2012-07-24
• Results First Submitted QC: 2012-07-24
• Results First Posted: 2012-08-28
• Study Completion: 2012-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemo therapy followed by thalidomide	surgery	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Chemo therapy followed by thalidomide	thalidomide	After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

Primary Outcome Measures

Name	Time	Method
Time to Progression	9 hours	Time to progression after surgery was recorded.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	60 months after treatment
Number of Events of Toxicity Graded 3 and 4	up to 60 months	Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States