CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
5-fluorouracil +2 moredrug
Likely dose
5-fluorouracil 4000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00555672
NCT00555672Phase 1Completed
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A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Pfizer·interventional·Posted Nov 9, 2007·Updated Dec 19, 2011

In Brief

A Phase 1 clinical trial evaluating 5-fluorouracil, cisplatin, and 1 other intervention for Stomach Neoplasms. Completed, enrolled 34 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStomach Neoplasms
CountriesSpain
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2007
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.6 years ago

Interventions

5-fluorouracildrug

5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

cisplatindrug

Cisplatin is given 80 mg/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.

sunitinib malatedrug

sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.