Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer

Completed · Phase 2

Conditions studied: Gastroesophageal Cancer

In brief

The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.

Key facts

Study ID

NCT02317991

Run by

SCRI Development Innovations, LLC

People needed

65

Starts

2015-05-05

Expected to finish

2021-05-21

Last updated by the study team

2022-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed metastatic adenocarcinoma of the esophagus, GE junction, or stomach who progressed on one prior line of chemotherapy in the metastatic setting.
• Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Adequate hematologic, renal, and hepatic functions
• Patients must have < Grade 2 pre-existing peripheral neuropathy (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 4.03)
• Life expectancy > 3 months

You may not qualify if…

• Patients who have received any other investigational agents, chemotherapy, biologic therapy, or radiation therapy within the 28 days prior to Day 1 of the study. For investigational, chemotherapy, or biologic therapy, patients will be allowed on study if five half-lives or greater have elapsed since last dose of drug or 28 days, whichever is shorter.
• Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic mechanisms.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety or compliance with study requirements or may interfere with the interpretation of the results.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study initiation, or anticipation of need for major surgical procedure during the course of the study.
• Evidence or history of uncontrolled hypertension, proteinuria, non-healing wound, ulcer, bone fracture, hemoptysis, valvular disease, abdominal fistula, GI perforation, intra-abdominal abscess, bleeding diathesis or coagulopathy that would exclude patients from treatment with anti-angiogenesis agents.
• Therapeutic anticoagulation with coumarin-derivatives will not be permitted. However, a maximum daily dose of 1 mg will be permitted for port line patency. Anticoagulation with low molecular weight heparin or anti-Factor Xa agents will be allowed.
• Patients with other concurrent severe and/or uncontrolled medical disease which could compromise safety of treatment as so judged by treating physician (i.e., severely impaired lung function, severe infection, ventricular arrhythmias active ischemic heart disease, known active vasculitis of any cause, chronic liver or renal disease).

Where it is running

• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Florida Cancer Specialists-South — Fort Myers, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Florida Cancer Specialists-North — St. Petersburg, Florida, United States
• Ingalls Cancer Research Center — Harvey, Illinois, United States
• Research Medical Center — Kansas City, Missouri, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Spartanburg Medical Center/Gibbs Cancer Center — Spartanburg, South Carolina, United States
• Tennessee Oncology — Chattanooga, Tennessee, United States
• Tennessee Oncology PLLC — Nashville, Tennessee, United States
• Center for Cancer and Blood Disorders — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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