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Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

NCT ID: NCT00609622

Last Updated: 2012-10-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Conditions

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Colorectal Neoplasms

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Treatment arm A - sunitinib plus mFOLFOX6

Group Type EXPERIMENTAL

sunitinib

Intervention Type DRUG

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).

mFOLFOX6

Intervention Type DRUG

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

B

Treatment arm B - bevacizumab plus mFOLFOX6

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.

mFOLFOX6

Intervention Type DRUG

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Interventions

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sunitinib

Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).

Intervention Type DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Intervention Type DRUG

bevacizumab

Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.

Intervention Type DRUG

mFOLFOX6

FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Intervention Type DRUG

Other Intervention Names

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Sutent, SU011248 Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fairhope, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Bentonville, Arkansas, United States

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Fayetteville, Arkansas, United States

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Hot Springs, Arkansas, United States

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Bakersfield, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Hills, California, United States

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Northrige, California, United States

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Oxnard, California, United States

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Pasadena, California, United States

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Redondo Beach, California, United States

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Santa Barbara, California, United States

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Santa Maria, California, United States

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Santa Monica, California, United States

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Solvang, California, United States

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Valencia, California, United States

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Jasonville, Florida, United States

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Orange Park, Florida, United States

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Palatka, Florida, United States

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Saint Augustine, Florida, United States

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Stuart, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Sandy Springs, Georgia, United States

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Maryville, Illinois, United States

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Chanute, Kansas, United States

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Dodge City, Kansas, United States

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El Dorado, Kansas, United States

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Independence, Kansas, United States

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Kingman, Kansas, United States

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Liberal, Kansas, United States

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Newton, Kansas, United States

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Parsons, Kansas, United States

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Salina, Kansas, United States

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Wellington, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Winfield, Kansas, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Columbus, Mississippi, United States

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Corinth, Mississippi, United States

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Tupelo, Mississippi, United States

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Columbia, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Meadowbrook, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Radnor, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Beaumont, Texas, United States

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Lubbock, Texas, United States

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Wenatchee, Washington, United States

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Aalborg, , Denmark

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Herlev, , Denmark

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Koebenhavn OE, , Denmark

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Aschaffenburg, , Germany

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Bad Saarow, , Germany

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Berlin, , Germany

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Düsseldorf, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Regensburg, , Germany

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Kashiwa, Chiba, Japan

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Sapporo, Hokkaido, Japan

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Kitaadachi-gun, Ina-cho, Saitama, Japan

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Suntougun, Shizuoka, Japan

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Utsunomiya, Tochigi, Japan

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Chuo-ku, Tokyo, Japan

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Countries

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United States Denmark Germany Japan

References

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Breen DM, Kim H, Bennett D, Calle RA, Collins S, Esquejo RM, He T, Joaquim S, Joyce A, Lambert M, Lin L, Pettersen B, Qiao S, Rossulek M, Weber G, Wu Z, Zhang BB, Birnbaum MJ. GDF-15 Neutralization Alleviates Platinum-Based Chemotherapy-Induced Emesis, Anorexia, and Weight Loss in Mice and Nonhuman Primates. Cell Metab. 2020 Dec 1;32(6):938-950.e6. doi: 10.1016/j.cmet.2020.10.023. Epub 2020 Nov 17.

Reference Type DERIVED
PMID: 33207247 (View on PubMed)

Hecht JR, Mitchell EP, Yoshino T, Welslau M, Lin X, Chow Maneval E, Paolini J, Lechuga MJ, Kretzschmar A. 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study. Cancer Manag Res. 2015 Jun 15;7:165-73. doi: 10.2147/CMAR.S61408. eCollection 2015.

Reference Type DERIVED
PMID: 26109878 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181104&StudyName=Randomized%20Study%20Of%20Sunitinib%20Plus%20FOLFOX%20Versus%20Bevacizumab%20Plus%20FOLFOX%20In%20Metastatic%20Colorectal%20Cancer

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

Other Identifiers

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A6181104

Identifier Type: -

Identifier Source: org_study_id