Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165217
First received: September 9, 2005
Last updated: December 20, 2007
Last verified: December 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma |
Resource links provided by NLM:
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) |
- 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00165217 History of Changes |
| Other Study ID Numbers: | 01-141 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
capecitabine thalidomide colorectal cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Thalidomide Fluorouracil Capecitabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013