Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00457691

Purpose

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: 5 fluorouracil Drug: irinotecan Drug: levo- leucovorin Drug: sunitinib Drug: placebo	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Sunitinib Sunitinib malate Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment.

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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Objective Response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Patient Reported Outcomes [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	720
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 5 fluorouracil 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days Drug: irinotecan 180mg/m2 iv day 1 every 14 days Drug: levo- leucovorin 200mg/m2 iv; day 1 every 14 days Drug: sunitinib 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
2: Placebo Comparator	Drug: 5 fluorouracil 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days Drug: irinotecan 180mg/m2 iv day 1 every 14 days Drug: levo- leucovorin 200mg/m2 iv; day 1 every 14 days Drug: placebo 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
Adequate organ function defined by blood test.

Exclusion Criteria:

History of another primary cancer in the last 3 years.
Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457691

Show 136 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181122
Study First Received:	April 4, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00457691
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Digestive System Diseases
Sunitinib
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Growth Inhibitors
Angiogenesis Modulating Agents
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009