CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Nab-paclitaxel 150 mg/m^2 +3 moredrug
Likely dose
Nab-paclitaxel 150 mg/m^2from 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/NCT03283761
NCT03283761Phase 2Completed
CompareCT.gov

A Phase II Study of FOLFOX Combined With Nab-Paclitaxel (FOLFOX-A) in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma. Big Ten Cancer Research Consortium: BTCRC-GI15-015

Al B. Benson, III, MD·interventional·Posted Sep 14, 2017·Updated Feb 6, 2024

In Brief

A Phase 2 clinical trial evaluating Nab-paclitaxel 150 mg/m^2, Oxaliplatin 85 mg/m^2, and 2 other interventions for Gastro-Esophageal Junction Adenocarcinoma and Gastric Cancer. Completed, enrolled 39 participants across 8 sites.

Detailed Summary

This is an open label, single-arm phase II, multi-institutional trial to evaluate the efficacy and safety of the combination of nab-paclitaxel and FOLFOX (FOLFOX-A) as first line therapy for patients diagnosed with histologically-confirmed advanced gastric/GEJ adenocarcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastro-Esophageal Junction Adenocarcinoma, Gastric Cancer
CountriesUnited States
CollaboratorsCelgene Corporation, Big Ten Cancer Research Consortium

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartSep 21, 2017
Primary CompletionDec 27, 2022
Study CompletionJan 16, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.8 years ago

Interventions

Nab-paclitaxel 150 mg/m^2drug

Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15

Oxaliplatin 85 mg/m^2drug

Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15

5-FU 1200 mg/m^2 x 2 Ddrug

Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16

Leucovorin 400 mg/m^2drug

Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15