Protocol Number: 99-C-0102

Title:

A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients with Recurrent Colorectal Cancer

Number:

99-C-0102

Summary:

This study will examine whether giving the drug thalidomide to patients after surgery for recurrent or metastatic colon cancer can improve their survival rate. (Metastatic cancer is disease that has spread beyond the original, or primary, site.) Surgical removal of recurrent or metastatic colorectal tumors may cure 20 to 30 percent of patients. In the remaining 70 to 80 percent of patients who undergo this surgery, however, the tumor returns within 2 years. Thalidomide is a medicine that prevents the growth of new blood vessels. When the blood supply to a tumor is slowed or stopped and the cells don't get sufficient oxygen and nutrients, the tumor growth may also slow or stop.

Patients 18 years of age and older who have had surgery for recurrent or metastatic colon or rectal cancer may be eligible for this study. Their surgery must have been performed within 12 weeks of enrollment in the study. Candidates are screened with a physical examination, blood tests, X-rays, and scans to evaluate their disease. Patients must be disease-free at the time of enrollment.

Participants are randomly assigned to receive treatment with either thalidomide or placebo. (A placebo is a pill that looks like the treatment drug but contains no active ingredient.) Since there is no therapy that is known to help when added to surgery for metastatic colorectal cancer, patients in the placebo group in this study are receiving what is considered standard care. The dose of the treatment drug (placebo or thalidomide) is increased every 4 weeks from a starting dose of 100 mg up to a final dose of 300 mg. Patients take the medicine once a day at bedtime every day for up to 24 months. If significant side effects occur at any dose, the dose may be adjusted. If the side effects persist, the medicine is stopped. Any patient whose tumor returns during treatment is taken off the study and may be eligible for standard chemotherapy, additional surgery, or other experimental studies.

Patients in both treatment groups are evaluated with scans and blood tests every 3 months during the thalidomide treatment period and for up to 36 months after treatment.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Anti-Angiogenesis

Surgery

Colon

Adenocarcinoma

Metastatic

Recruitment Keyword(s):

None

Condition(s):

Colorectal Neoplasm

Neoplasm Metastasis

Investigational Drug(s):

Thalidomide

Investigational Device(s):

None

Interventions:

Drug: Thalidomide

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Resection of liver metastases from colorectal cancer Indications and results

Pulmonary resection of metastatic colorectal adenocarcinoma A ten year experience

Results of pulmonary resection of metastatic colorectal cancer and its application

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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