A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

NCT00615056 | Completed Phase 2 Results

• 1 other identifier: A4061034
• Study Type: interventional
• Target: 171
• Locations: 8 countries
• Sites: 83

Brief Summary

The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

  Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks

Secondary Outcomes (5)

• Overall Survival (OS)

  Baseline until death or up to 1 year after the randomization of last participant

• Percentage of Participants With Objective Response (OR)

  Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

• Duration of Response (DR)

  Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

• Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI-D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal

  Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal

• Change From Baseline in MDASI-D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal

  Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal

Study Arms (4)

B

ACTIVE COMPARATOR

Bevacizumab (avastin)

Drug: Bevacizumab (avastin); Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])

C

EXPERIMENTAL

AG-013736 (axitinib)

Drug: AG-013736 (axitinib); Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

A

EXPERIMENTAL

AG-013736 (axitinib)

Drug: AG-013736 (axitinib); Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

D

ACTIVE COMPARATOR

bevacizumab (avastin)

Drug: Bevacizumab (avastin); Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Interventions

Bevacizumab (avastin) DRUG

Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

B

FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) DRUG

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

B

AG-013736 (axitinib) DRUG

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

C

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) DRUG

Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

C

Eligibility Criteria

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

You may qualify if:

• Histologically documented colorectal cancer plus one of the following:
• Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
• Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

You may not qualify if:

• Prior treatment in first line metastatic setting with more than one regimen
• Prior irradiation of more than 25% of bone marrow.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (83)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Antioch, California, 94531, United States

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Los Angeles, California, 90095-6984, United States

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Los Angeles, California, 90095, United States

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Pleasant Hill, California, 94523, United States

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San Leandro, California, 94578, United States

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Santa Monica, California, 90404, United States

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Aurora, Colorado, 80045, United States

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Bonita Springs, Florida, 34135, United States

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Bradenton, Florida, 34209, United States

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Cape Coral, Florida, 33914, United States

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Cape Coral, Florida, 33990, United States

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Englewood, Florida, 34223, United States

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Fort Myers, Florida, 33901-8108, United States

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Fort Myers, Florida, 33905, United States

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Fort Myers, Florida, 33908, United States

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Fort Myers, Florida, 33916, United States

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Naples, Florida, 34102, United States

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Naples, Florida, 34119, United States

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Port Charlotte, Florida, 33980, United States

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Sarasota, Florida, 34232, United States

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Sarasota, Florida, 34236, United States

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Venice, Florida, 34285, United States

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Venice, Florida, 34292, United States

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Atlanta, Georgia, 30318, United States

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Ringgold, Georgia, 30736, United States

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Dubuque, Iowa, 52001, United States

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Crestview Hills, Kentucky, 41017, United States

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Paducah, Kentucky, 42002, United States

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Paducah, Kentucky, 42003, United States

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Baltimore, Maryland, 21237, United States

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New Albany, Mississippi, 38652, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45230, United States

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Cincinnati, Ohio, 45236, United States

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Cincinnati, Ohio, 45238, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45248, United States

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Fairfield, Ohio, 45014, United States

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Hamilton, Ohio, 45013, United States

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Chattanooga, Tennessee, 37404, United States

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Franklin, Tennessee, 37067, United States

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Gallatin, Tennessee, 37066, United States

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Germantown, Tennessee, 38138, United States

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Hermitage, Tennessee, 37076, United States

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Hixson, Tennessee, 37343, United States

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Lebanon, Tennessee, 37087, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37207, United States

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Nashville, Tennessee, 37211, United States

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Nashville, Tennessee, 37232, United States

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Paris, Tennessee, 38242, United States

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Smyrna, Tennessee, 37167, United States

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Union City, Tennessee, 38261, United States

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Corpus Christi, Texas, 78463, United States

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Mechanicsville, Virginia, 23116, United States

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Midlothian, Virginia, 23114, United States

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Richmond, Virginia, 23230, United States

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Richmond, Virginia, 23235, United States

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Greenfield Park, Quebec, J4V 2H1, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Lille, 59020, France

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Montpellier, 34094, France

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Paris, 75012, France

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Villejuif, 94805, France

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Genova, 16132, Italy

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Padua, 35128, Italy

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Roma, 00152, Italy

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Roma, 00168, Italy

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Kashiwa, Chiba, Japan

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Suntougun, Shizuoka, Japan

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Chuo-ku, Tokyo, Japan

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Warsaw, 02-097, Poland

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Warsaw, 02-781, Poland

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Daegu, 700-721, South Korea

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Jeollanam-do, 519-809, South Korea

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Seoul, 139-706, South Korea

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Sabadell, Barcelona, 08208, Spain

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Madrid, Madrid, 28033, Spain

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Irinotecan; Leucovorin; Fluorouracil; Axitinib; Folfox protocol; Oxaliplatin

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Coordination Complexes

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 19, 2013
• Results First Posted: April 20, 2012

Record last verified: 2013-04

Locations

US (61); JP (3); KR (3); CA (3); FR (4); ES (3); IT (4); PL (2)