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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02317991
Recruitment Status : Active, not recruiting
First Posted : December 17, 2014
Last Update Posted : August 18, 2020
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Cancer Drug: nab-paclitaxel Biological: ramucirumab Phase 2

Detailed Description:
Adenocarcinoma of the esophagus and the gastroesophageal junction (GE junction) is the ninth most common cancer worldwide. Ramucirumab (Cyramza®), a monoclonal antibody, is approved as a single agent and in combination with paclitaxel as a treatment for patients with metastatic gastric or GE junction adenocarcinoma whose cancer has progressed after prior chemotherapy. Nab-paclitaxel (Abraxane®) is an albumin-based formulation of paclitaxel which was developed to improve the therapeutic index and reduce toxicity. Nab-paclitaxel is approved in over 40 countries/regions for treatment of various metastatic cancers including breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. In this Phase II study, the investigators propose to combine the less toxic nab-paclitaxel to increase tumor uptake of the drug and improve efficacy while minimizing side effects. The biological rationale of using this combination is that ramucirumab will inhibit tumor angiogenesis and nab-paclitaxel will induce apoptosis of the rapidly dividing tumor cell.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Nab-Paclitaxel and Ramucirumab for the Second-line Treatment of Patients With Metastatic Gastroesophageal Cancer
Actual Study Start Date : May 5, 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nab-paclitaxel and ramucirumab

All patients will receive 125 mg/m^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).

Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.

Drug: nab-paclitaxel
nab-paclitaxel 125 mg/m^2 IV
Other Names:
  • Abraxane
  • ABI-007

Biological: ramucirumab
Ramucirumab 8 mg/kg IV
Other Names:
  • Cyramza
  • IMC-1121B

Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: up to 1 year from last subject in ]
    Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST) v1.1, or death on study from any cause.

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: every 8 weeks up to 1 year ]
    Defined as the proportion of patients with confirmed complete response or partial response (CR or PR) according to RECIST v1.1

  2. Time to Progression (TTP) [ Time Frame: up to 1 year from last subject in ]
    Defined as the time from Day 1 of study drug administration to disease progression per RECIST v1.1.

  3. Overall Survival (OS) [ Time Frame: up to 1 year from last subject in ]
    Measured from Day 1 of study drug administration to death from any cause.

Other Outcome Measures:
  1. Reported incidence of adverse events as a measure of safety and tolerability [ Time Frame: Patients will be followed for duration of treatment, expected average of 6 months ]
    Defined according to CTCAE v4.03

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  4. Adequate hematologic, renal, and hepatic functions
  5. Patients must have < Grade 2 pre-existing peripheral neuropathy (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 4.03)
  6. Life expectancy > 3 months

Exclusion Criteria:

  1. 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.
  2. Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic mechanisms.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02317991

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United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists-South
Fort Myers, Florida, United States, 33916
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Florida Cancer Specialists-North
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60425
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Spartanburg Medical Center/Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Tennessee Oncology
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
SCRI Development Innovations, LLC
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Study Chair: Johanna Bendell, M.D. SCRI Development Innovations, LLC
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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT02317991    
Other Study ID Numbers: SCRI GI 201
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SCRI Development Innovations, LLC:
gastroesophageal adenocarcinoma
GE junction
Additional relevant MeSH terms:
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Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action