Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 439 for:    colon cancer AND Capecitabine

Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00120172
Recruitment Status : Terminated (positive results from a larger study with same regimen was released.)
First Posted : July 15, 2005
Last Update Posted : November 16, 2007
Sponsor:
Collaborator:
Sanofi
Information provided by:
Geriatric Oncology Consortium

Tracking Information
First Submitted Date  ICMJE July 8, 2005
First Posted Date  ICMJE July 15, 2005
Last Update Posted Date November 16, 2007
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2005)
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00120172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2005)
  • Overall response
  • Duration of response
  • Safety and tolerability (NCI CTCAE v3.0, discontinuations, dose intensity)
  • Vulnerable Elders Survey (VES-13) and Geriatric Depression Scale (GDS) scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
Official Title  ICMJE A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
Brief Summary Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.
Detailed Description Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Neoplasm Metastasis
Intervention  ICMJE Drug: oxaliplatin, capecitabine, bevacizumab
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 8, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65 years and above;
  • Histologically or cytologically documented adenocarcinoma of the colon or rectum;
  • Metastatic disease;
  • Measurable disease or assessable but nonmeasurable disease allowed;
  • ECOG 0-1
  • No prior oxaliplatin or bevacizumab.
  • No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;
  • No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);
  • No bleeding diathesis or coagulopathy
  • Adequate renal and hepatic functions as per protocol;
  • Signed informed consent

Exclusion Criteria:

  • Clinically significant cardiovascular or peripheral vascular disease;
  • Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;
  • Serious non-healing wound, ulcer, or bone fracture;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00120172
Other Study ID Numbers  ICMJE GOC-GI-010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Geriatric Oncology Consortium
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Chair: Stuart Lichtman, MD Geriatric Oncology Consortium
PRS Account Geriatric Oncology Consortium
Verification Date November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP