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


Phase 2
20 Years
N/A
Not Enrolling
Both
Unresectable or Metastatic Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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.

Outcome Time Frame:

Up to 11 cycles (1 cycle = 6 weeks)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A6181151

NCT ID:

NCT00668863

Start Date:

May 2008

Completion Date:

September 2010

Related Keywords:

  • Unresectable or Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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