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Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00631410
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : August 17, 2010
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 2, 2008
First Posted Date  ICMJE March 7, 2008
Results First Submitted Date  ICMJE July 21, 2010
Results First Posted Date  ICMJE August 17, 2010
Last Update Posted Date March 16, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Number of Participants With Adverse Events [ Time Frame: Up to 733 days (the last subject study discontinuation) ]
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities by CTCAE criteria [ Time Frame: 01-Dec-2009 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
  • Plasma Concentration of Sunitinib [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]
    Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
  • Plasma Concentration of Sunitinib Active Metabolite (SU012662) [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]
    Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
  • Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]
    Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.
  • Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to the last subject completed Cycle 24 or individual study discontinuation ]
    Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.
  • Duration of Response (DR) [ Time Frame: Up to 733 days (the last subject study discontinuation) ]
    Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.
  • Progression-Free Survival (PFS) [ Time Frame: Up to 733 days (the last subject study discontinuation) ]
    Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.
  • Sunitinib Relative Dose Intensity in the Treatment Arm A [ Time Frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A) ]
    Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)*3+1 to n*3.
  • Sunitinib Relative Dose Intensity in the Treatment Arm B [ Time Frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B) ]
    Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)*2+1 to n*2.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • Objective tumor response (confirmed complete and partial response) [ Time Frame: 01-Dec-2009 ]
  • Pharmacokinetics of sunitinib and its active metabolite, SU012662 [ Time Frame: 01-Dec-2009 ]
  • Relative dose intensity [ Time Frame: 01-Dec-2009 ]
  • Progression-Free Survival (PFS) [ Time Frame: 01-Dec-2009 ]
  • Duration of Response (DR) [ Time Frame: 01-Dec-2009 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Official Title  ICMJE Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
Brief Summary To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Drug: sunitinib + mFOLFOX6
    37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
  • Drug: sunitinib + mFOLFOX6
    50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: sunitinib + mFOLFOX6
  • Experimental: B
    Intervention: Drug: sunitinib + mFOLFOX6
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
  • Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
  • Prior surgery or investigational agent within 4 weeks prior to study entry.
  • Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631410
Other Study ID Numbers  ICMJE A6181148
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP