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

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byAl B. Benson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Al B. Benson, III, MD

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Al B. Benson, MD

Principal Investigator

Big Ten Cancer Research Consortium

Eligibility Criteria

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

Age ≥ 18 years at the time of consent.

ECOG Performance Status of 0-1 within 28 days prior to registration.

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Exclusion Criteria

You are allergic to fluorouracil, oxaliplatin, or other similar chemotherapy drugs.

Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing is not required).

Has known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not required)

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Treatment Details

Interventions

5-FU (Anti-metabolites)
Leucovorin (Other)
Nab-paclitaxel (Anti-tumor antibiotic)
Oxaliplatin (Alkylating agents)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment4 Interventions

All patients in Stage I (N=12) and Stage II (N=25) 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/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 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.

5-FU is already approved in Canada, Japan for the following indications: