Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Stomach Neoplasms

Treatments: Drug: capecitabine; Drug: oxaliplatin; Drug: cisplatin; Drug: sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555620

A6181126

Details and patient eligibility

About

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• prior chemotherapy for the 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: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: capecitabine

Drug: oxaliplatin

Drug: sunitinib malate

Drug: capecitabine

Drug: sunitinib malate

B

Experimental group

Treatment:

Drug: capecitabine

Drug: cisplatin

Drug: sunitinib malate

Drug: capecitabine

Drug: sunitinib malate