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

September 10, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Pfizer Investigational Site
      • Herlev, Denmark, 2730
        • Pfizer Investigational Site
      • Koebenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Pfizer Investigational Site
      • Bad Saarow, Germany, 15526
        • Pfizer Investigational Site
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Duesseldorf, Germany, 40225
        • Pfizer Investigational Site
      • Magdeburg, Germany, 39104
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Regensburg, Germany, 93053
        • Pfizer Investigational Site
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Pfizer Investigational Site
    • Saitama
      • Kitaadachi-gun, Ina-cho, Saitama, Japan
        • Pfizer Investigational Site
    • Shizuoka
      • Suntougun, Shizuoka, Japan
        • Pfizer Investigational Site
    • Tochigi
      • Utsunomiya, Tochigi, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36604
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Pfizer Investigational Site
      • Mesa, Arizona, United States, 85206
        • Pfizer Investigational Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pfizer Investigational Site
      • Fayetteville, Arkansas, United States, 72703
        • Pfizer Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Lancaster, California, United States, 93534
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095-1772
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095-6984
        • Pfizer Investigational Site
      • Mission Hills, California, United States, 91345
        • Pfizer Investigational Site
      • Northrige, California, United States, 91325
        • Pfizer Investigational Site
      • Oxnard, California, United States, 93030
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
      • Redondo Beach, California, United States, 90277
        • Pfizer Investigational Site
      • Santa Barbara, California, United States, 93105
        • Pfizer Investigational Site
      • Santa Maria, California, United States, 93454
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
      • Solvang, California, United States, 93436
        • Pfizer Investigational Site
      • Valencia, California, United States, 91355
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32605
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32258
        • Pfizer Investigational Site
      • Jacksonville Beach, Florida, United States, 32250
        • Pfizer Investigational Site
      • Jasonville, Florida, United States, 32207
        • Pfizer Investigational Site
      • Orange Park, Florida, United States, 32073
        • Pfizer Investigational Site
      • Palatka, Florida, United States, 32177
        • Pfizer Investigational Site
      • St. Augustine, Florida, United States, 32086
        • Pfizer Investigational Site
      • Stuart, Florida, United States, 34994
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
      • Sandy Springs, Georgia, United States, 30342
        • Pfizer Investigational Site
    • Illinois
      • Maryville, Illinois, United States, 62062
        • Pfizer Investigational Site
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Pfizer Investigational Site
      • Dodge City, Kansas, United States, 67801
        • Pfizer Investigational Site
      • El Dorado, Kansas, United States, 67042
        • Pfizer Investigational Site
      • Independence, Kansas, United States, 67301
        • Pfizer Investigational Site
      • Kingman, Kansas, United States, 67068
        • Pfizer Investigational Site
      • Liberal, Kansas, United States, 67905
        • Pfizer Investigational Site
      • Newton, Kansas, United States, 67114
        • Pfizer Investigational Site
      • Parsons, Kansas, United States, 67357
        • Pfizer Investigational Site
      • Salina, Kansas, United States, 67401
        • Pfizer Investigational Site
      • Wellington, Kansas, United States, 67152
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67208
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
      • Winfield, Kansas, United States, 67156
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21225
        • Pfizer Investigational Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Pfizer Investigational Site
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89169
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73102
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73109
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Pfizer Investigational Site
    • Pennsylvania
      • Meadowbrook, Pennsylvania, United States, 19046
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Pfizer Investigational Site
      • Radnor, Pennsylvania, United States, 19087
        • Pfizer Investigational Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Lubbock, Texas, United States, 79415
        • Pfizer Investigational Site
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Treatment arm A - sunitinib plus mFOLFOX6
Drug: sunitinib
Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
Other Names:
  • Sutent, SU011248
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
Active Comparator: B
Treatment arm B - bevacizumab plus mFOLFOX6
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
Drug: bevacizumab
Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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)
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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
Time Frame: 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)
One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
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
Time Frame: 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)
Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.
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)
Time Frame: 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
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
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)
Time Frame: 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
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
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
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score
Time Frame: 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)
FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.
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)
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score
Time Frame: Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)
FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.
Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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