Clinical trial NCT00609622: Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 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)
measure: One Year Survival Probability
timeFrame: 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)
measure: Two Year Survival Probability
timeFrame: 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)
measure: Percentage of Participants With Objective Response (OR)
timeFrame: 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
measure: Duration of Response (DR)
timeFrame: 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
measure: Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score
timeFrame: Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)
measure: Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score
timeFrame: Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Bentonville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fayetteville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Northrige
country: United States
facility: Pfizer Investigational Site
state: California
city: Oxnard
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Barbara
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Maria
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Solvang
country: United States
facility: Pfizer Investigational Site
state: California
city: Valencia
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jasonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palatka
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Augustine
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Maryville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chanute
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Dodge City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: El Dorado
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Independence
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Kingman
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Liberal
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Parsons
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Salina
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wellington
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Winfield
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Meadowbrook
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Radnor
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Aschaffenburg
country: Germany
facility: Pfizer Investigational Site
city: Bad Saarow
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Regensburg
country: Germany
facility: Pfizer Investigational Site
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kitaadachi-gun, Ina-cho
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Suntougun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.