NCT03283761

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Al B. Benson, III, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m2 and leucovorin IV 400 mg/m2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.

Conditions

• Gastro-Esophageal Junction Adenocarcinoma
• Gastric Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-21
• Primary completion: 2022-12-27
• Completion: 2023-01-16
• First posted: 2017-09-14
• Last updated: 2024-02-06
• Results posted: 2024-02-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study