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Colorectal NeoplasmsPhase 2NCT00609622

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

A Phase 2 study testing sunitinib, mFOLFOX6 and bevacizumab in people with Colorectal Neoplasms, run by Pfizer at 97 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
sunitinib, mFOLFOX6 and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
97 sitesin 4 countries
Study dates
Apr 2008to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

97 sites in 4 countries.

97 sites in 4 countries

United States81 sites

  • Pfizer Investigational Site

    Atlanta, Georgia, 30341

  • Pfizer Investigational Site

    Aurora, Colorado, 80045

  • Pfizer Investigational Site

    Bakersfield, California, 93309

  • Pfizer Investigational Site

    Baltimore, Maryland, 21225

  • Pfizer Investigational Site

    Baltimore, Maryland, 21237

  • Pfizer Investigational Site

    Beaumont, Texas, 77701

  • Pfizer Investigational Site

    Bentonville, Arkansas, 72712

  • Pfizer Investigational Site

    Chandler, Arizona, 85224

  • Pfizer Investigational Site

    Chanute, Kansas, 66720

  • Pfizer Investigational Site

    Columbia, Missouri, 65203

  • Pfizer Investigational Site

    Columbus, Mississippi, 39705

  • Pfizer Investigational Site

    Corinth, Mississippi, 38834

  • Pfizer Investigational Site

    Decatur, Georgia, 30033

  • Pfizer Investigational Site

    Dodge City, Kansas, 67801

  • Pfizer Investigational Site

    El Dorado, Kansas, 67042

  • Pfizer Investigational Site

    Fairhope, Alabama, 36532

  • Pfizer Investigational Site

    Fayetteville, Arkansas, 72703

  • Pfizer Investigational Site

    Fresno, California, 93720

  • Pfizer Investigational Site

    Fullerton, California, 92835

  • Pfizer Investigational Site

    Gainesville, Florida, 32605

  • Pfizer Investigational Site

    Henderson, Nevada, 89052

  • Pfizer Investigational Site

    Hot Springs, Arkansas, 71913

  • Pfizer Investigational Site

    Independence, Kansas, 67301

  • Pfizer Investigational Site

    Jacksonville, Florida, 32204

  • Pfizer Investigational Site

    Jacksonville, Florida, 32207

  • Pfizer Investigational Site

    Jacksonville, Florida, 32258

  • Pfizer Investigational Site

    Jacksonville Beach, Florida, 32250

  • Pfizer Investigational Site

    Jasonville, Florida, 32207

  • Pfizer Investigational Site

    Kingman, Kansas, 67068

  • Pfizer Investigational Site

    Lancaster, California, 93534

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89128

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89148

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89169

  • Pfizer Investigational Site

    Liberal, Kansas, 67905

  • Pfizer Investigational Site

    Los Angeles, California, 90095-1772

  • Pfizer Investigational Site

    Los Angeles, California, 90095-6984

  • Pfizer Investigational Site

    Los Angeles, California, 90095

  • Pfizer Investigational Site

    Lubbock, Texas, 79415

  • Pfizer Investigational Site

    Macon, Georgia, 31217

  • Pfizer Investigational Site

    Marietta, Georgia, 30060

  • Pfizer Investigational Site

    Maryville, Illinois, 62062

  • Pfizer Investigational Site

    Meadowbrook, Pennsylvania, 19046

  • Pfizer Investigational Site

    Mesa, Arizona, 85206

  • Pfizer Investigational Site

    Mission Hills, California, 91345

  • Pfizer Investigational Site

    Mobile, Alabama, 36604

  • Pfizer Investigational Site

    Newton, Kansas, 67114

  • Pfizer Investigational Site

    Norman, Oklahoma, 73071

  • Pfizer Investigational Site

    Northrige, California, 91325

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73109

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73120

  • Pfizer Investigational Site

    Orange Park, Florida, 32073

  • Pfizer Investigational Site

    Oxnard, California, 93030

  • Pfizer Investigational Site

    Palatka, Florida, 32177

  • Pfizer Investigational Site

    Parsons, Kansas, 67357

  • Pfizer Investigational Site

    Pasadena, California, 91105

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19106

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Pfizer Investigational Site

    Portland, Oregon, 97227

  • Pfizer Investigational Site

    Radnor, Pennsylvania, 19087

  • Pfizer Investigational Site

    Redondo Beach, California, 90277

  • Pfizer Investigational Site

    Saint Augustine, Florida, 32086

  • Pfizer Investigational Site

    Salina, Kansas, 67401

  • Pfizer Investigational Site

    Sandy Springs, Georgia, 30342

  • Pfizer Investigational Site

    Santa Barbara, California, 93105

  • Pfizer Investigational Site

    Santa Maria, California, 93454

  • Pfizer Investigational Site

    Santa Monica, California, 90404

  • Pfizer Investigational Site

    Solvang, California, 93436

  • Pfizer Investigational Site

    Stuart, Florida, 34994

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801

  • Pfizer Investigational Site

    Valencia, California, 91355

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20007

  • Pfizer Investigational Site

    Wellington, Kansas, 67152

  • Pfizer Investigational Site

    Wenatchee, Washington, 98801

  • Pfizer Investigational Site

    Wichita, Kansas, 67208

  • Pfizer Investigational Site

    Wichita, Kansas, 67214

  • Pfizer Investigational Site

    Willow Grove, Pennsylvania, 19090

  • Pfizer Investigational Site

    Winfield, Kansas, 67156

Other trials in United States

Germany7 sites

  • Pfizer Investigational Site

    Aschaffenburg, 63739

  • Pfizer Investigational Site

    Bad Saarow, 15526

  • Pfizer Investigational Site

    Berlin, 13125

  • Pfizer Investigational Site

    Düsseldorf, 40225

  • Pfizer Investigational Site

    Magdeburg, 39104

  • Pfizer Investigational Site

    Mainz, 55131

  • Pfizer Investigational Site

    Regensburg, 93053

Other trials in Germany

Japan6 sites

  • Pfizer Investigational Site

    Chuo-ku, Tokyo

  • Pfizer Investigational Site

    Kashiwa, Chiba

  • Pfizer Investigational Site

    Kitaadachi-gun, Ina-cho, Saitama

  • Pfizer Investigational Site

    Sapporo, Hokkaido

  • Pfizer Investigational Site

    Suntougun, Shizuoka

  • Pfizer Investigational Site

    Utsunomiya, Tochigi

Other trials in Japan

Denmark3 sites

  • Pfizer Investigational Site

    Aalborg, 9100

  • Pfizer Investigational Site

    Herlev, 2730

  • Pfizer Investigational Site

    Koebenhavn OE, 2100

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
sunitinib, mFOLFOX6, bevacizumab
Keywords
metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinibDrug

    Also called Sutent, SU011248

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

  • mFOLFOX6Drug

    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

  • bevacizumabDrug

    Also called Avastin

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

  • mFOLFOX6Drug

    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

Study groups in NCT00609622
Study groupRoleWhat they receive
AExperimentalTreatment arm A - sunitinib plus mFOLFOX6
Receives: Drug: sunitinib; Drug: mFOLFOX6
BActive comparatorTreatment arm B - bevacizumab plus mFOLFOX6
Receives: Drug: bevacizumab; Drug: mFOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  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").

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

Secondary outcomes (7)

  1. Overall Survival (OS)

    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).

    Measured: 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)

  2. One Year Survival Probability

    One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.

    Measured: 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)

  3. Two Year Survival Probability

    Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.

    Measured: 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)

  4. Percentage of Participants With Objective Response (OR)

    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.

    Measured: 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

  5. Duration of Response (DR)

    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.

    Measured: 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

  6. Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score

    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.

    Measured: 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)

  7. Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score

    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.

    Measured: Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609622
Sponsor's protocol ID
A6181104
Status last verified
Sep 2012
First submitted
25 Jan 2008
Last updated
11 Oct 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 33207247

  • 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.

    PubMed 26109878

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib, mFOLFOX6 and bevacizumab in people with Colorectal Neoplasms, run by Pfizer at 97 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Germany, Japan, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00609622, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.

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