A Randomized, Double Blind Placebo Controlled Phase 2 Study of FOLFOX Plus or Minus GDC-0449 in Patients With Advanced Gastric and Gastroesophageal Junction (GEJ) Carcinoma

Study Status

Closed to Enrollment

Study Description

Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. GDC-0449 may block the growth of tumor cells. It is not yet known whether combination chemotherapy is more effective when given with or without GDC-0449 in treating stomach cancer and gastroesophageal junction cancer (GEJ).

The purpose of this clinical trial is to study giving combination chemotherapy together with GDC-0449 to see how well it works compared with giving combination chemotherapy without GDC-0449 in treating patients with advanced stomach cancer or gastroesophageal junction cancer.

Patients will be randomly assigned to one of two study arms:

Arm 1:

  • FOLFOX (oxaliplatin, leucovorin calcium, and fluorouracil) chemotherapy plus placebo (a product that looks like GDC-0449 but does not contain medicine)

Arm 2:

  • FOLFOX chemotherapy plus GDC-0449

Disease Status and/or Stage

Gastric or Gastroesophageal Junction (GEJ) Cancer Not Amenable to Surgical Resection

Sponsor

New York Cancer Consortium

Key Eligibility

  • Men and women age 18 and older
  • Gastric or gastroesophageal junction (GEJ) cancer not amenable to surgical resection
  • More than 6 months since prior adjuvant chemotherapy or chemoradiation No prior chemotherapy for advanced disease
  • Detailed eligibility discussed when you contact the study team

Principal Investigator

Allyson Ocean, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
roh2026@med.cornell.edu

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