Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

NCT00159432 | Completed Phase 2 Results

• 1 other identifier: 3C-04-10
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. This study is being done to find out how long it takes tumors to grow after patients receive the drugs capecitabine, oxaliplatin and bevacizumab. Capecitabine (also called Xeloda) is a drug that has been approved by the FDA for treatment of advanced colorectal cancer. Capecitabine prevents some colorectal cancer cancer cells from reproducing, and causes some of them to die. Oxaliplatin (also called Eloxatin) has also been approved by the FDA for treatment of advanced colorectal cancer. Oxaliplatin prevents some colorectal cancer cells from reproducing. Bevacizumab is an investigational drug. Bevacizumab is an antibody (a protein that acts against a specific substance) directed against vascular endothelial growth factor (VEGF). VEGF promotes the growth of blood vessels that bring nutrients to cells. Bevacizumab inhibits the growth of colon cancer cells, by blocking the effects of VEGF. The combination of the drugs used in this study is experimental. The purpose of this study is to see how long it takes patients' tumors to grow when they are taking this combination of drugs.

Conditions

Colorectal Cancer

Keywords

colorectal; cancer

Outcome Measures

Primary Outcomes (1)

• Median Time for Progression Free Survival

  Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.

  Up to 6 years

Secondary Outcomes (1)

• Number of Participants With Grade 3 or Higher Toxicity

  Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.

Study Arms (1)

Oxaliplatin, followed by Bevacizumab with Capecitabine

EXPERIMENTAL

oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily

Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

Also known as: Eloxatin

Oxaliplatin, followed by Bevacizumab with Capecitabine

Bevacizumab DRUG

Also known as: Avastin

Oxaliplatin, followed by Bevacizumab with Capecitabine

Capecitabine DRUG

Also known as: Xeloda

Oxaliplatin, followed by Bevacizumab with Capecitabine

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
• Age greater than or equal to 18 years
• SWOG performance status 0-1.
• At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques.
• Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
• Availability of tumor biopsy (paraffin embedded or fresh frozen) at the time of diagnosis and/or prior to study entry is required.
• Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.

You may not qualify if:

• Pregnant or lactating woman.
• Life expectancy \< 3 months.
• Serious, uncontrolled, concurrent infection(s) or illness(es)
• Any prior oxaliplatin treatment, with the exception of adjuvant therapy given \> 12 months prior to the beginning of study therapy
• Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency
• Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months.
• History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
• History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
• Presence of central nervous system or brain mets.
• Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Any of the following laboratory values:

Sponsors & Collaborators

• University of Southern California: lead
• Hoffmann-La Roche: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

U.S.C./Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Hurwitz H, Mitchell EP, Cartwright T, Kwok A, Hu S, McKenna E, Patt YZ. A randomized, phase II trial of standard triweekly compared with dose-dense biweekly capecitabine plus oxaliplatin plus bevacizumab as first-line treatment for metastatic colorectal cancer: XELOX-A-DVS (dense versus standard). Oncologist. 2012;17(7):937-46. doi: 10.1634/theoncologist.2012-0071. Epub 2012 May 23.

  PMID: 22622147 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Oxaliplatin; Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Victoria Soto, Project Specialist
• Organization: USC Norris Comprehensive Cancer Center

victoria.soto@med.usc.edu

323-226-6384

Study Officials

• Syma Iqbal, M.D.

  U.S.C. Norris Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: March 1, 2013
• Last Updated: July 29, 2014
• Results First Posted: January 15, 2014

Record last verified: 2014-07

Locations

US (1)