A Phase II Study Of Sunitinib In Combination With Irinotecan, L-leucovorin, And 5-Fluorouracil In Patients With Unresectable Or Metastatic Colorectal Cancer

Pfizer1 site in 1 country71 target enrollmentMay 2008

ConditionsUnresectable or Metastatic Colorectal Cancer

InterventionsFOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)Sunitinib

DrugsFOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)Sunitinib

Overview

Phase: Phase 2
Intervention: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)
Conditions: Unresectable or Metastatic Colorectal Cancer
Sponsor: Pfizer
Enrollment: 71
Locations: 1
Primary Endpoint: Progression-Free Survival (PFS)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
•Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.

Exclusion Criteria

•History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
•Current, recent, or planned participation in an experimental treatment drug study other than this protocol.

Arms & Interventions

1

Intervention: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)

1

Intervention: Sunitinib

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: Up to 11 cycles (1 cycle = 6 weeks)

PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis.

Secondary Outcomes

Overall Survival (OS)(Up to 11 cycles (1 cycle = 6 weeks))
Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)(Up to 11 cycles (1 cycle = 6 weeks))
Duration of Response (DR)(Up to 11 cycles (1 cycle = 6 weeks))
Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.(Cycle 1 Day 15)
Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib(Cycle 1 Day 15)
Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib(Cycle 1 Day 15)
Apparent Oral Clearance (CL/F) of Sunitinib(Cycle 1 Day 15)
Maximum Observed Plasma Concentration (Cmax) of Irinotecan(Cycle 1 Day 15)
Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan(Cycle 1 Day 15)
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan(Cycle 1 Day 15)
Terminal Phase Elimination Half-life (t1/2) of Irinotecan(Cycle 1 Day 15)
Clearance of Irinotecan(Cycle 1 Day 15)
Volume of Distribution at Steady State (Vss) of Irinotecan(Cycle 1 Day 15)
Plasma Concentration at Steady State (Css) of 5-FU(Cycle 1 Day 15)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).(Up to 11 cycles (1 cycle = 6 weeks))