CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
fluorouracil +6 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/NCT01231399
NCT01231399Phase 2Completed
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Phase Ib Trial of mFOLFOX6 and Everolimus (NSC-733504) in Patients With Metastatic Gastroesophageal Adenocarcinoma

City of Hope Medical Center·interventional·Posted Nov 1, 2010·Updated May 31, 2017

In Brief

A Phase 2 clinical trial evaluating fluorouracil, leucovorin calcium, and 5 other interventions for Adenocarcinoma of the Esophagus and 8 related conditions. Completed, enrolled 6 participants across 3 sites.

Detailed Summary

RATIONALE: Everolimus may stop the growth of stomach or esophageal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Giving everolimus together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with combination chemotherapy in treating patients with metastatic stomach or esophageal cancer that has spread to other places in the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartFeb 1, 2012
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.7 years ago

Interventions

fluorouracildrug

Given IV

leucovorin calciumdrug

Given IV

oxaliplatindrug

Given IV

everolimusdrug

Given orally

laboratory biomarker analysisother

Correlative studies

immunohistochemistry staining methodother

Correlative studies

microarray analysisgenetic

Correlative studies