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FOLFOX-A in the Treatment of Metastatic or Advanced Unresectable Gastric, Gastro-Esophageal Junction Adenocarcinoma

NCT03283761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-02-06

Study results available
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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.

Conditions

Interventions

DRUG

Nab-paclitaxel 150 mg/m^2

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

DRUG

Oxaliplatin 85 mg/m^2

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

DRUG

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

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

DRUG

Leucovorin 400 mg/m^2

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Al B. Benson, III, MD

    lead OTHER

Principal Investigators

  • Al B. Benson, MD · Big Ten Cancer Research Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2022-12-27
Completion
2023-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03283761 on ClinicalTrials.gov