CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
oxaliplatin +5 moredrug
Likely dose
Not stated in 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/NCT00982592
NCT00982592Phase 2Completed

A Randomized, Double Blind Placebo Controlled Phase 2 Study of FOLFOX Plus or Minus GDC-0449 in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Carcinoma

National Cancer Institute (NCI)·interventional·Posted Sep 23, 2009·Updated Jan 25, 2016

In Brief

A Phase 2 clinical trial evaluating oxaliplatin, leucovorin calcium, and 4 other interventions for Adenocarcinoma of the Gastroesophageal Junction and 6 related conditions. Completed, enrolled 124 participants across 30 sites.

Detailed Summary

This randomized phase II trial studies combination chemotherapy when given together with vismodegib to see how well it works compared with combination chemotherapy without vismodegib in treating patients with advanced stomach cancer or gastroesophageal junction cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Vismodegib may stop the growth of stomach or gastroesophageal junction cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether combination chemotherapy is more effective when given with or without vismodegib in treating stomach cancer and gastroesophageal junction cancer.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2012
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.8 years ago

Interventions

oxaliplatindrug

Given IV

leucovorin calciumdrug

Given IV

fluorouracildrug

Given IV

placeboother

Given PO

vismodegibdrug

Given PO

laboratory biomarker analysisother

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