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

NCT00120172 | Terminated Phase 2

• 1 other identifier: GOC-GI-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Colorectal Cancer; Neoplasm Metastasis

Keywords

colorectal; metastatic; elderly; metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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

Interventions

oxaliplatin, capecitabine, bevacizumab DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Geriatric Oncology Consortium: lead
• Sanofi: collaborator

Study Sites (5)

Unknown Facility

Mission Hills, California, 91345, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Inverness, Florida, 34452, United States

Location

Unknown Facility

New Port Richey, Florida, 34652, United States

Location

Unknown Facility

Coeur d'Alene, Idaho, 83814, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Oxaliplatin; Capecitabine; Bevacizumab

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stuart Lichtman, MD

  Geriatric Oncology Consortium

  STUDY CHAIR

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: July 8, 2005
• First Posted: July 15, 2005
• Study Start: May 1, 2005
• Study Completion: June 1, 2006
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

US (5)