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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

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").

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181104

NCT ID:

NCT00609622

Start Date:

April 2008

Completion Date:

July 2011

Related Keywords:

  • Colorectal Neoplasms
  • metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Washington, District of Columbia  20007-2197