Title: 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-GI15-0151

Principal Investigators: Al Benson, MD, Northwestern University Feinberg School of Medicine

Description: For this open-label, phase 2 study, researchers are evaluating the safety and efficacy of FOLFOX plus nab-paclitaxel (FOLFOX-A) as a first-line therapy for patients with histologically confirmed advanced gastric cancer or adenocarcinoma of the gastroesophageal junction.

Patients with stage I and II disease will receive FOLFOX-A every 2 weeks for each 4 week cycle. Intravenous (IV) nab-paclitaxel will be administered over 30 minutes, followed by IV oxaliplatin and IV leucovorin over 2 hours, as well as IV 5-FU as continuous infusion over Days 1 and 2.

The primary outcome measure is the 2-year overall objective response rate. Secondary outcome measures include overall survival, progression-free survival, time to progression, best overall response rate, best disease control rate, and adverse events. All outcomes will be evaluated over 5 years.

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The estimated enrollment is 39 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03283761.

Status: This study is open and recruiting patients as of October 26, 2017.

This study is sponsored by Al B. Benson, III, MD, in collaboration with Celgene Corporation and the Big Ten Cancer Research Consortium.

Reference

  1. Clinicaltrials.gov. FOLFOX-A in the treatment of metastatic or advanced unresectable gastric, gastro-esophageal junction adenocarcinoma. NCT03283761. https://clinicaltrials.gov/ct2/show/NCT03283761. Accessed October 26, 2017.