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 |
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.
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
Fayetteville, Arkansas 72703
Principal Investigator: Joseph Beck
Phone: 479-587-1700
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201 Dowman Dr
Atlanta, Georgia 30303
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
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
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
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
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
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
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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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
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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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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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333 Cedar St
New Haven, Connecticut 06504
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
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
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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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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