Clinical trial NCT00019747
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer
Sponsor: National Institutes of Health Clinical Center (CC)
Start date: 1999-08-01; Completion date: 2008-12-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer.

Detailed description:
OBJECTIVES:

* Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
* Compare the time to recurrence in patients treated with these regimens.
* Determine whether serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels, as well as carcinoembryonic antigen (CEA) measurements, aid in predicting time to recurrence in these patients.
* Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients.
* Determine whether patients receiving thalidomide develop measurable antiangiogenic activity.
* Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease (lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sites\[including sites that were both resected and ablated\]). Patients without evidence of residual disease are randomized to one of two treatment arms.

* Arm I: Patients receive oral thalidomide once daily.
* Arm II: Patients receive an oral placebo once daily. Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 94 patients (47 per treatment arm) will be accrued for this study within 3 years.

Arms: arm 1: Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). arm 2: Patients receive oral placebo once daily.
Interventions: intervention 1: thalidomide intervention 2: adjuvant therapy intervention 3: Placebo
Intervention descriptions: intervention 1: oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). intervention 2: Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs. intervention 3: oral placebo once daily

Protocol documents: