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 - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00615056

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: Bevacizumab (avastin) Drug: FOLFIRI (Irinotecan, leucovorin, 5FU) Drug: AG-013736 (axitinib) Drug: FOLFOX (oxaliplatin, leucovorin, 5 FU) Drug: FOLFIRI (irinotecan, leucovorin, 5 FU)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Irinotecan U 101440E Irinotecan hydrochloride Bevacizumab Axitinib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare outcome of quality of life as tested by M.D. Anderson Symptoms Inventory-Diarrhea (MDASI-D) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety profile of AG-013736: Safety profile characterized by laboratory abnormalities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety profile of AG-013736: Safety profile characterized by type, grade and frequency of all adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	171
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2012
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B Bevacizumab (avastin)	Drug: Bevacizumab (avastin) Bevacizumab IV infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. Drug: FOLFIRI (Irinotecan, leucovorin, 5FU) Irinotecan (180 mg/m²) IV infusion over 90 minutes, concurrently with leucovorin (400 mg/m²) IV over 2 hours followed immediately by 5-FU bolus (400 mg/m²) 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.
Experimental: C AG-013736 (axitinib)	Drug: AG-013736 (axitinib) Axitinib is given at a starting dose of 5 mg BID continuous dosing until disease progression, intolerance or withdrawal of consent. Drug: FOLFOX (oxaliplatin, leucovorin, 5 FU) Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) 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.
Experimental: A AG-013736 (axitinib)	Drug: AG-013736 (axitinib) Axitinib is given at a starting dose of 5 mg BID continuous dosing until disease progression, intolerance or withdrawal of consent. Drug: FOLFIRI (irinotecan, leucovorin, 5 FU) Irinotecan (180 mg/m²) IV infusion over 90 minutes, concurrently with leucovorin (400 mg/m²) IV over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV 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.
Active Comparator: D bevacizumab (avastin)	Drug: Bevacizumab (avastin) Bevacizumab IV infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. Drug: FOLFOX (oxaliplatin, leucovorin, 5 FU) Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615056

Show 84 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00615056 History of Changes
Other Study ID Numbers:	A4061034
Study First Received:	February 1, 2008
Last Updated:	January 14, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Bevacizumab

Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012