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Protocol No. UW17139

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Institutional

Title 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

Objective The purpose of this study is to find out if a drug called nab-paclitaxel plus a combination chemotherapy regime called FOLFOX have any effect on stomach cancer or cancer where the esophagus and the stomach meet. The study drugs could shrink your cancer but could also cause side effects

Treatment All participants will receive the same dose of nab-paclitaxel and FOLFOX(oxaliplatin, leucovorin, and 5-fluorouracil)

Description A phase II study of nab-paclitaxel and FOLFOX in treatment of metastatic or advanced unresectable stomach cancer or cancer where the stomach and the esophagus meet.

Key Eligibility
  • Histologically-confirmed advanced or metastatic unresectable gastric carcinoma, or adenocarcinoma of the gastroesophageal junction.
  • Measurable disease according to RECIST v1.1
  • Adequate liver, renal and bone marrow organ function
  • No prior systemic treatment is allowed.
  • Her-2 positive gastric tumor
  • Preexisting peripheral neuropathy is not allowed from any cause.
  • Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C (baseline testing is not required)
  • Patients with active sepsis or pneumonitis
  • Known hypersensitivity to fluorouracil (5-FU), oxaliplatin, or other platinum agents.
  • Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency (testing not required)
  • Ongoing or active infection requiring systemic treatment (must be afebrile for ≥ 48 hours prior to study registration)
  • Uncontrolled intercurrent illness including, but not limited to any of the following: symptomatic congestive heart failure,unstable angina pectoris, or cardiac arrhythmia

  • Applicable Disease Sites Esophagus; Stomach

    Status Open

    Participating Institutions UW Hospital and Clinics