Study Of Sunitinib With FOLFIRI In Colorectal Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Unresectable or Metastatic Colorectal Cancer

Treatments: Drug: Sunitinib; Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668863

A6181151

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Sunitinib

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