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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00631410
First received: January 2, 2008
Last updated: March 11, 2011
Last verified: March 2011

January 2, 2008
March 11, 2011
January 2008
July 2009   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events [ Time Frame: Up to 733 days (the last subject study discontinuation) ] [ Designated as safety issue: Yes ]
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.
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities by CTCAE criteria [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00631410 on ClinicalTrials.gov Archive Site
  • Plasma Concentration of Sunitinib [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
  • Relative dose intensity [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: No ]
  • Objective tumor response (confirmed complete and partial response) [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of sunitinib and its active metabolite, SU012662 [ Time Frame: 01-Dec-2009 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
  • 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)
  • Experimental: A
    Intervention: Drug: sunitinib + mFOLFOX6
  • Experimental: B
    Intervention: Drug: sunitinib + mFOLFOX6
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2010
July 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00631410
A6181148
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

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