Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00609622

Purpose

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: sunitinib + mFOLFOX6 Drug: bevacizumab + mFOLFOX6	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Bevacizumab Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival and 1- and 2-year survival rates [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Objective response rate and duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Patient reported outcomes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Type, incidence, severity, timing, seriousness, and relatedness of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	290
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Treatment arm A - sunitinib plus mFOLFOX6	Drug: sunitinib + mFOLFOX6 Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2). FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 (or 200 mg/m2 l-leucovorin) as a 2-hr IV infusion 5-fluorouracil 400 mg/m2 IV bolus 5-fluorouracil 2400 mg/m2 IV infusion over 46 hours
B: Active Comparator Treatment arm B - bevacizumab plus mFOLFOX6	Drug: bevacizumab + mFOLFOX6 Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks. FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 (or 200 mg/m2 l-leucovorin) as a 2-hr IV infusion 5-fluorouracil 400 mg/m2 IV bolus 5-fluorouracil 2400 mg/m2 IV infusion over 46 hours

Arms

Assigned Interventions

A: Experimental

Treatment arm A - sunitinib plus mFOLFOX6

Drug: sunitinib + mFOLFOX6

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2). FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of:

oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 (or 200 mg/m2 l-leucovorin) as a 2-hr IV infusion
5-fluorouracil 400 mg/m2 IV bolus
5-fluorouracil 2400 mg/m2 IV infusion over 46 hours

B: Active Comparator

Treatment arm B - bevacizumab plus mFOLFOX6

Drug: bevacizumab + mFOLFOX6

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks. FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of:

oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 (or 200 mg/m2 l-leucovorin) as a 2-hr IV infusion
5-fluorouracil 400 mg/m2 IV bolus
5-fluorouracil 2400 mg/m2 IV infusion over 46 hours

Eligibility

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

Criteria

Inclusion Criteria:

Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
History of cardiac disease
Brain mets

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609622

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 109 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 Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181104
Study First Received:	January 25, 2008
Last Updated:	November 15, 2009
ClinicalTrials.gov Identifier:	NCT00609622 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study

Additional relevant MeSH terms:

Colorectal Neoplasms
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Bevacizumab
Rectal Diseases
Neoplasms by Site
Sunitinib
Therapeutic Uses

Growth Inhibitors
Angiogenesis Modulating Agents
Digestive System Neoplasms
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009