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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Colorectal Neoplasms

Treatments: Drug: sunitinib + mFOLFOX6

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631410

A6181148

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: sunitinib + mFOLFOX6

Drug: sunitinib + mFOLFOX6

B

Experimental group

Treatment:

Drug: sunitinib + mFOLFOX6

Drug: sunitinib + mFOLFOX6