Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00599924

Purpose

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX. Several dosing regimens will be tested in patients with advanced solid tumors, including colorectal cancer.

Condition	Intervention	Phase
Colorectal Neoplasms Neoplasms	Drug: sunitinib + FOLFOX	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies

Further study details as provided by Pfizer:

Primary Outcome Measures:

Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities [ Time Frame: March 09 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective disease response [ Time Frame: March 09 ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), oxaliplatin, and 5-FU [ Time Frame: March 09 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2005
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single arm: Experimental SU011248 in combination with FOLFOX	Drug: sunitinib + FOLFOX 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day)

Eligibility

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

Criteria

Inclusion Criteria:

Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)
ECOG 0 or 1

Exclusion Criteria:

Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens
Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens
For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599924

Locations

United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246

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:	A6181048
Study First Received:	January 11, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00599924 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced solid tumors, colorectal cancer, sunitinib (SUTENT), FOLFOX

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Sunitinib
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Sunitinib
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009