Conditions: Carcinoma of the Appendix Colorectal Cancer
Keywords: carcinoma of the appendix stage II colon cancer stage III colon cancer stage IV colon cancer recurrent colon cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer recurrent rectal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

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.

Arms:
arm 1: After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

Interventions: intervention 1: thalidomide intervention 2: surgery
Intervention descriptions: intervention 1: Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected. intervention 2: Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Protocol document: