A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT00642603 | Terminated Phase 2 Results

• 1 other identifier: ML21567
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 76

Brief Summary

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) in U.S. Patients Only

  PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

  From first patient enrolled up to approximately 48 months

Study Arms (2)

XELOX + bevacizumab (Q2W)

EXPERIMENTAL

Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: oxaliplatin

XELIRI + bevacizumab (Q2W)

EXPERIMENTAL

Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: irinotecan

Interventions

capecitabine [Xeloda] DRUG

1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

XELOX + bevacizumab (Q2W)

bevacizumab [Avastin] DRUG

5 mg/kg taken intravenously on Day 1 of each 2 week cycle

XELIRI + bevacizumab (Q2W); XELOX + bevacizumab (Q2W)

oxaliplatin DRUG

85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

XELOX + bevacizumab (Q2W)

irinotecan DRUG

135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

XELIRI + bevacizumab (Q2W)

Eligibility Criteria

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

You may qualify if:

• Adult patients, ≥18 years of age
• Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
• ≥1 measurable target lesion
• Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

You may not qualify if:

• Prior systemic therapy for advanced or metastatic disease
• History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
• Clinically significant cardiovascular disease
• Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
• Chronic daily treatment with \>325 mg/day aspirin

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (76)

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PARK Springs, Arizona, 71913, United States

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Sedona, Arizona, 86336, United States

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Tucson, Arizona, 85712, United States

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Anaheim, California, 92801, United States

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Colton, California, 92324, United States

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Greenbrae, California, 94904, United States

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Loma Linda, California, 92354, United States

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Modesto, California, 95355, United States

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Montebello, California, 90640, United States

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Pomona, California, 91767, United States

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Sacramento, California, 95816, United States

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Norwich, Connecticut, 06360, United States

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Waterbury, Connecticut, 06708, United States

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Lake Worth, Florida, 33431, United States

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Miami Shores, Florida, 33179, United States

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New Port Richey, Florida, 34655, United States

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Ocala, Florida, 34474, United States

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Ocoee, Florida, 34761, United States

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Marietta, Georgia, 30060, United States

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Niles, Illinois, 60714, United States

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Paducah, Kentucky, 42002, United States

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Alexandria, Louisiana, 71301, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21237, United States

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Westminster, Maryland, 21157, United States

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Pittsfield, Massachusetts, 01201, United States

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Worcester, Massachusetts, 01608, United States

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Kalamazoo, Michigan, 49048, United States

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Duluth, Minnesota, 55805, United States

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Jefferson City, Missouri, 65109, United States

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Great Falls, Montana, 59405, United States

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Las Vegas, Nevada, 89109, United States

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Neptune City, New Jersey, 07754, United States

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Albuquerque, New Mexico, 87102, United States

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Albuquerque, New Mexico, 87131-5636, United States

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Santa Fe, New Mexico, 87505, United States

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Brooklyn, New York, 11219, United States

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Huntington Station, New York, 11746, United States

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Durham, North Carolina, 27710, United States

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Hickory, North Carolina, 28602, United States

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Canton, Ohio, 44718, United States

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Eugene, Oregon, 97401-8122, United States

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Ephrata, Pennsylvania, 17522, United States

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Langhorne, Pennsylvania, 19047, United States

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Philadelphia, Pennsylvania, 19102, United States

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Scranton, Pennsylvania, 18510, United States

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Charleston, South Carolina, 29403-5740, United States

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Charleston, South Carolina, 29406, United States

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Florence, South Carolina, 29506, United States

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Sumter, South Carolina, 29150, United States

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Chattanooga, Tennessee, 37404, United States

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Cookeville, Tennessee, 38501, United States

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Nashville, Tennessee, 37203, United States

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Amarillo, Texas, 79106, United States

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Arlington, Texas, 76014, United States

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Beaumont, Texas, 77702-1449, United States

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Bedford, Texas, 76022, United States

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Carrollton, Texas, 75010, United States

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Corpus Christi, Texas, 78412, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75237, United States

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Fort Worth, Texas, 76104, United States

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Garland, Texas, 75042, United States

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Lewisville, Texas, 75067, United States

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Mesquite, Texas, 75150, United States

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Paris, Texas, 75460, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78229, United States

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Southlake, Texas, 76092, United States

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Sugar Land, Texas, 77479, United States

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Waco, Texas, 76712, United States

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Webster, Texas, 77598-4420, United States

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Salt Lake City, Utah, 84106, United States

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Christiansburg, Virginia, 24073, United States

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Seattle, Washington, 98133, United States

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Bevacizumab; Oxaliplatin; Irinotecan

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Limitations and Caveats

This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 29, 2018
• Results First Posted: June 23, 2011

Record last verified: 2018-02

Locations

US (76)