Leucovorin 400 mg/m^2 for Gastroesophageal Junction Adenocarcinoma

Phase 2

Waitlist Available

Led By Al B. Benson, MD

Research Sponsored by Al B. Benson, III, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from c1d1 until death or up to a maximum of 52 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combination to see if it is effective and safe for patients with stomach or gastroesophageal junction cancer.

Eligible Conditions

Gastroesophageal Junction Adenocarcinoma
Stomach Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from c1d1 until death or up to a maximum of 52 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from c1d1 until death or up to a maximum of 52 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death or up to a maximum of 52 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Secondary study objectives

Disease Control Rate (DCR)

Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin 400 mg/m^2

2017

Completed Phase 2

~40

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

2017

Completed Phase 2

~40