Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

NCT00165217 | Completed Phase 2

• 1 other identifier: 01-141
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Adenocarcinoma

Keywords

capecitabine; thalidomide; colorectal cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• To evaluate the safety of capecitabine and thalidomide in this patient population.

Interventions

Capecitabine DRUG

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• ECOG performance status of less than or equal to 2
• Life expectancy of greater than 12 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Thalidomide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles S. Fuchs, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

US (2)