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

NCT00555620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2013-01-14

Study results available
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Summary

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

Conditions

  • Stomach Neoplasms

Interventions

DRUG

capecitabine

Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.

DRUG

oxaliplatin

Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

DRUG

sunitinib malate

sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

DRUG

capecitabine

Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.

DRUG

cisplatin

Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

DRUG

sunitinib malate

sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-08-31
Completion
2011-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555620 on ClinicalTrials.gov