A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:January 20, 2015
End Date:July 31, 2019

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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a
targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine
and cisplatin alone in participants with stomach cancer.


Inclusion Criteria:

- Have a histopathologically confirmed diagnosis of metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell
origin including undifferentiated gastric carcinoma are eligible.

- Have not received any prior first-line systemic therapy (prior adjuvant or
neo-adjuvant therapy is permitted). Participants whose disease has progressed after
>12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant
setting are eligible.

- Have measurable or nonmeasurable but evaluable disease determined using guidelines in
Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline
tumor assessment should be performed using a high resolution computed tomography (CT)
scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance
imaging (MRI) is acceptable if a CT cannot be performed.

- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at
baseline.

- Have adequate organ function.

- Have baseline clinical and laboratory parameters that are consistent with the
requirements prescribed in respective labels and are suitable for consideration of
treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine
dehydrogenase deficiency).

- Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Exclusion Criteria:

- Participants with adenocarcinoma of the esophagus are excluded.

- Participants with human epidermal growth factor receptor 2 (HER2)-positive status.

- Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.

- Have radiation therapy within 14 days prior to randomization.

- Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord
compression.

- Have significant bleeding disorders, vasculitis, or had a significant bleeding episode
from the gastrointestinal tract within 12 weeks prior to randomization.

- Have experienced any arterial thromboembolic event, including myocardial infarction,
unstable angina, cerebrovascular accident, or transient ischemic attack, within 6
months prior to randomization.

- Have symptomatic congestive heart failure (New York Heart Association II-IV) or
symptomatic or poorly controlled cardiac arrhythmia.

- Have uncontrolled hypertension prior to initiating study treatment, despite
antihypertensive intervention.

- Have undergone major surgery within 28 days prior to randomization, or central venous
access device placement within 7 days prior to first dose of study treatment, except
if the procedure is minimally invasive (for example, introduction of peripherally
inserted central catheter [PICC] line) and the investigator does not anticipate any
significant bleeding.

- Have a history of gastrointestinal perforation and/or fistulae within 6 months prior
to randomization.

- Have a history of inflammatory bowel disease or Crohn's disease requiring medical
intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months
prior to randomization.

- Have an acute or subacute bowel obstruction or history of chronic diarrhea which is
considered clinically significant in the opinion of the investigator.

- The participant has:

- cirrhosis at a level of Child-Pugh B (or worse) or

- cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is
defined as ascites resulting from cirrhosis and requiring ongoing treatment with
diuretics and/or paracentesis.

- Have known allergy or hypersensitivity to any components of study treatment.

- Are pregnant or lactating.
We found this trial at
26
sites
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Walid Shaib
Phone: 404-778-2670
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Daniel Dammrich
Phone: 954-267-7706
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: James Reeves
Phone: 239-274-9930
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Benjamin Musher
Phone: 713-798-2500
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Aurora, Colorado 80045
Principal Investigator: Stephen Leong
Phone: 720-848-0000
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Bakersfield, California 93309
Principal Investigator: Ravi Patel
Phone: 661-322-2206
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: CHARLES FUCHS
Phone: 617-632-5869
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Irfan Firdaus
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: UDIT VERMA
Phone: 214-648-7031
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph Beck
Phone: 479-587-1700
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Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5900
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Los Angeles, California 90024
Principal Investigator: TRIO -Translational Research
Phone: 310-824-1934
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Zev Wainberg
Phone: 310-824-1934
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Nashville, Tennessee 37203
Principal Investigator: James Reeves
Phone: 615-329-7615
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Jill Lacy
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
Principal Investigator: Manish Shah
Phone: 646-962-9343
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Elizabeth Won
Phone: 212-639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Peoria, Illinois 61615
Principal Investigator: Madhuri Bajaj
Phone: 309-243-3000
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Philadelphia, Pennsylvania 19111
Principal Investigator: Crystal Denlinger
Phone: 215-214-1451
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Moses Raj
Phone: 412-359-6220
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Redondo Beach, California 90277
Principal Investigator: Hugo Hool
Phone: 310-750-3376
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Saint Petersburg, Florida 33705
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San Luis Obispo, California 93401
Principal Investigator: Brian DiCarlo
Phone: 805-739-3724
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Santa Monica, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-739-3724
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