Back to resultsStudy Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
sunitinib + mFOLFOX6
sunitinib + mFOLFOX6
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Phase 1, CRC, SU011248, Sunitinib, FOLFOX, Colorectal cancer, metastatic carcinoma of the colon or rectum
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
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.
Secondary Outcome Measures
Plasma Concentration of Sunitinib
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)
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)
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)
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)
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)
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631410
Brief Title
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Official Title
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Phase 1, CRC, SU011248, Sunitinib, FOLFOX, Colorectal cancer, metastatic carcinoma of the colon or rectum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sunitinib + mFOLFOX6
Intervention Description
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
Intervention Type
Drug
Intervention Name(s)
sunitinib + mFOLFOX6
Intervention Description
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Up to 733 days (the last subject study discontinuation)
Secondary Outcome Measure Information:
Title
Plasma Concentration of Sunitinib
Description
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.
Time Frame
Cycle 1 Day 14 and Cycle 2 Day 1
Title
Plasma Concentration of Sunitinib Active Metabolite (SU012662)
Description
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.
Time Frame
Cycle 1 Day 14 and Cycle 2 Day 1
Title
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
Description
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.
Time Frame
Cycle 1 Day 14 and Cycle 2 Day 1
Title
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Description
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.
Time Frame
Up to the last subject completed Cycle 24 or individual study discontinuation
Title
Duration of Response (DR)
Description
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.
Time Frame
Up to 733 days (the last subject study discontinuation)
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Up to 733 days (the last subject study discontinuation)
Title
Sunitinib Relative Dose Intensity in the Treatment Arm A
Description
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.
Time Frame
Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
Title
Sunitinib Relative Dose Intensity in the Treatment Arm B
Description
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.
Time Frame
Up to 384 days (the last subject study discontinuation in the Treatment Arm B)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suntougun
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181148&StudyName=Study%20Of%20Sunitinib%20In%20Combination%20With%20Folfox%20In%20Patients%20With%20Colorectal%20Cancer
Description
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Learn more about this trial
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
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