ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

This study has been completed.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165217
  Purpose

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 Intervention Phase
Colorectal Adenocarcinoma
Drug: Capecitabine
Drug: Thalidomide
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Thalidomide    Capecitabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

Further study details as provided by Dana-Farber Cancer Institute:

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

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

Estimated Enrollment:   37
Study Start Date:   November 2001
Study Completion Date:   December 2005
Primary Completion Date:   December 2005 (Final data collection date for primary outcome measure)

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165217

Locations
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Massachusetts General Hospital    
      Boston, Massachusetts, United States, 02114

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital

Investigators
Principal Investigator:     Charles S. Fuchs, MD, MPH     Dana-Farber Cancer Institute    
  More Information


Study ID Numbers:   01-141
First Received:   September 9, 2005
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00165217
Health Authority:   United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
capecitabine  
thalidomide  
colorectal cancer  

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Thalidomide
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on October 23, 2008




Links to all studies - primarily for crawlers