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

NCT02317991 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SCRI GI 201
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

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.

Conditions

Gastroesophageal Cancer

Keywords

gastroesophageal adenocarcinoma; nab-paclitaxel; Abraxane; ramucirumab; Cyramza; GE junction

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.

  up to 1 year

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  every 8 weeks up to 1 year

• Time to Progression (TTP)

  up to 1 year

• Overall Survival (OS)

  up to 1 year

Other Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

  For duration of treatment, up to of 6 months

Study Arms (1)

nab-paclitaxel and ramucirumab

EXPERIMENTAL

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; Biological: ramucirumab

Interventions

nab-paclitaxel DRUG

nab-paclitaxel 125 mg/m\^2 IV

Also known as: Abraxane, ABI-007

nab-paclitaxel and ramucirumab

ramucirumab BIOLOGICAL

Ramucirumab 8 mg/kg IV

Also known as: Cyramza, IMC-1121B

nab-paclitaxel and ramucirumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Celgene: collaborator

Study Sites (11)

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists-South

Fort Myers, Florida, 33916, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists-North

St. Petersburg, Florida, 33705, United States

Location

Ingalls Cancer Research Center

Harvey, Illinois, 60425, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Spartanburg Medical Center/Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States

Location

Tennessee Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Ramucirumab

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

CANN.InnovationsMedical@sarahcannon.com

844-710-6157

Study Officials

• David Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 17, 2014
• Study Start: May 5, 2015
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Locations

US (11)