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Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

NCT00019747 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-10-28

Study results available
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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.

Conditions

Interventions

DRUG

thalidomide

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).

PROCEDURE

adjuvant therapy

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.

OTHER

Placebo

oral placebo once daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Steven K. Libutti, MD · NCI - Surgery Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00019747 on ClinicalTrials.gov