Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Stomach Neoplasms

Treatments: Drug: 5-fluorouracil; Drug: cisplatin; Drug: sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555672

A6181128

Details and patient eligibility

About

The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of stomach cancer
• advanced stomach cancer stage IV
• adequate blood chemistry, blood counts and kidney function
• willing to participate to study requirements and to sign an informed consent document

Exclusion criteria

• prior chemotherapy for stomach cancer in its advanced stage
• excessive toxicities related to prior therapies
• pregnant or breastfeeding patients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

A

Experimental group

Treatment:

Drug: 5-fluorouracil

Drug: cisplatin

Drug: sunitinib malate