Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165217
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 21, 2007
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Adenocarcinoma Drug: Capecitabine Drug: Thalidomide Phase 2

Detailed Description:
  • Patients will take capecitabine orally twice a day for two weeks followed by a one week break period. These three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects.
  • Thalidomide will be taken orally once daily in the evening. Each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects. The dose will be increased in this manner until the daily dose is 600mg. If side effects do develop, the dose will either be held constant or decreased until the side effects resolve. If the side effects do not resolve, treatment will be stopped.
  • Before starting treatment and periodically throughout the study, a physical exam, routine blood tests, scans and x-rays will be done to monitor the body's response to the treatment.
  • For women patients, pregnancy tests will be performed every 3 weeks while on therapy.
  • Scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to follow the effects of the study drugs on the tumor.

Study Type : Interventional  (Clinical Trial)
Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Study Start Date : November 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.

Secondary Outcome Measures :
  1. To evaluate the safety of capecitabine and thalidomide in this patient population.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease
  • Measurable tumor
  • Serum creatinine < 1.5 mg/dl
  • Total bilirubin < 2.0 mg/dl
  • AST < 5 x ULN
  • ANC > 1,500/mm3
  • Platelets > 100,000/mm3
  • Hemoglobin > 9.0 gm/dl
  • Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment
  • 18 years of age or older
  • ECOG performance status of less than or equal to 2
  • Life expectancy of greater than 12 weeks

Exclusion Criteria:

  • Prior treatment with mitomycin C or nitrosourea compounds
  • Prior treatment with capecitabine or thalidomide
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • Peripheral neuropathy of grade 2 or greater severity
  • Myocardial infarction in the past 6 months
  • Major surgery in the past 2 weeks
  • Uncontrolled serious medical or psychiatric illness
  • Pregnant or lactating women
  • Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Known allergy to 5-FU

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165217

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Principal Investigator: Charles S. Fuchs, MD, MPH Dana-Farber Cancer Institute Identifier: NCT00165217     History of Changes
Other Study ID Numbers: 01-141
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Dana-Farber Cancer Institute:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances