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

NCT00609622 | Terminated Phase 2 Results

• 1 other identifier: A6181104
• Study Type: interventional
• Target: 191
• Locations: 4 countries
• Sites: 97

Brief Summary

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.

Conditions

Colorectal Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

  Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

Secondary Outcomes (7)

• Overall Survival (OS)

  Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)

• One Year Survival Probability

  Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)

• Two Year Survival Probability

  Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)

• Percentage of Participants With Objective Response (OR)

  Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

• Duration of Response (DR)

  Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

Study Arms (2)

A

EXPERIMENTAL

Treatment arm A - sunitinib plus mFOLFOX6

Drug: sunitinib; Drug: mFOLFOX6

B

ACTIVE COMPARATOR

Treatment arm B - bevacizumab plus mFOLFOX6

Drug: bevacizumab; Drug: mFOLFOX6

Interventions

sunitinib DRUG

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

Also known as: Sutent, SU011248

A

mFOLFOX6 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

A

bevacizumab DRUG

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

Also known as: Avastin

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (97)

Pfizer Investigational Site

Fairhope, Alabama, 36532, United States

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Mobile, Alabama, 36604, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85206, United States

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Bentonville, Arkansas, 72712, United States

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Fayetteville, Arkansas, 72703, United States

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Hot Springs, Arkansas, 71913, United States

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Bakersfield, California, 93309, United States

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Fresno, California, 93720, United States

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Fullerton, California, 92835, United States

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Lancaster, California, 93534, United States

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Los Angeles, California, 90095-1772, United States

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Los Angeles, California, 90095-6984, United States

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Los Angeles, California, 90095, United States

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Mission Hills, California, 91345, United States

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Northrige, California, 91325, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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Redondo Beach, California, 90277, United States

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Santa Barbara, California, 93105, United States

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Santa Maria, California, 93454, United States

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Santa Monica, California, 90404, United States

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Solvang, California, 93436, United States

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Valencia, California, 91355, United States

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Aurora, Colorado, 80045, United States

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Washington D.C., District of Columbia, 20007, United States

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Gainesville, Florida, 32605, United States

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Jacksonville, Florida, 32204, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32258, United States

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Jacksonville Beach, Florida, 32250, United States

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Jasonville, Florida, 32207, United States

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Orange Park, Florida, 32073, United States

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Palatka, Florida, 32177, United States

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Saint Augustine, Florida, 32086, United States

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Stuart, Florida, 34994, United States

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Atlanta, Georgia, 30341, United States

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Decatur, Georgia, 30033, United States

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Macon, Georgia, 31217, United States

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Marietta, Georgia, 30060, United States

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Sandy Springs, Georgia, 30342, United States

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Maryville, Illinois, 62062, United States

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Chanute, Kansas, 66720, United States

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Dodge City, Kansas, 67801, United States

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El Dorado, Kansas, 67042, United States

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Independence, Kansas, 67301, United States

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Kingman, Kansas, 67068, United States

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Liberal, Kansas, 67905, United States

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Newton, Kansas, 67114, United States

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Parsons, Kansas, 67357, United States

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Salina, Kansas, 67401, United States

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Wellington, Kansas, 67152, United States

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Wichita, Kansas, 67208, United States

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Wichita, Kansas, 67214, United States

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Winfield, Kansas, 67156, United States

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Baltimore, Maryland, 21225, United States

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Baltimore, Maryland, 21237, United States

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Columbus, Mississippi, 39705, United States

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Corinth, Mississippi, 38834, United States

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Tupelo, Mississippi, 38801, United States

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Columbia, Missouri, 65203, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89148, United States

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Las Vegas, Nevada, 89169, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73102, United States

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Oklahoma City, Oklahoma, 73109, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Portland, Oregon, 97227, United States

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Meadowbrook, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19106, United States

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Philadelphia, Pennsylvania, 19107, United States

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Radnor, Pennsylvania, 19087, United States

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Willow Grove, Pennsylvania, 19090, United States

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Beaumont, Texas, 77701, United States

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Lubbock, Texas, 79415, United States

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Wenatchee, Washington, 98801, United States

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Aalborg, 9100, Denmark

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Herlev, 2730, Denmark

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Koebenhavn OE, 2100, Denmark

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Aschaffenburg, 63739, Germany

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Bad Saarow, 15526, Germany

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Berlin, 13125, Germany

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Düsseldorf, 40225, Germany

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Magdeburg, 39104, Germany

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Mainz, 55131, Germany

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Regensburg, 93053, 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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Related Publications (2)

• 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.

  PMID: 33207247 DERIVED

• 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.

  PMID: 26109878 DERIVED

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Sunitinib; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to early study termination, not all data was analyzable.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 11, 2012
• Results First Posted: October 11, 2012

Record last verified: 2012-09

Locations

DE (7); US (81); DK (3); JP (6)