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A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01246960
First received: November 8, 2010
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether ramucirumab when used in conjunction with chemotherapy treatment can help participants with stomach, esophagus, and gastroesophageal cancer.


Condition Intervention Phase
Stomach Cancer
Esophageal Cancer
Biological: Ramucirumab
Drug: Placebo
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product(IMC-1121B) Versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Baseline until measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Proportion of patients achieving an objective response (objective response rate) [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: Baseline to progressive disease ] [ Designated as safety issue: No ]
  • Incidence of anti-Ramucirumab antibodies [ Time Frame: Baseline through 30 day follow up visit ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Time of first response to the first date of progression of disease ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: April 2011
Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab
  • Oxaliplatin 85 milligrams per square meter (mg/m^2) given on Day 1 of a 2-week cycle
  • Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle
  • 5-Fluorouracil (5-FU) 400 mg/m^2 bolus given on Day 1 of a 2-week cycle
  • 5-FU 2400 mg/m^2 continuous gven over 46 - 48 hours on Day 1 of a 2-week cycle
  • Ramucirumab 8 milligrams per kilogram (mg/kg) given on Day 1 of a 2-week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Biological: Ramucirumab
Administered intravenously
Other Names:
  • LY3009806
  • IMC-1121B
Drug: Oxaliplatin
Administered intravenously
Drug: Leucovorin
Administered intravenously
Drug: 5-Fluorouracil
Administered intravenously
Placebo Comparator: Placebo
  • Oxaliplatin 85 mg/m^2 given on Day 1 of a 2-week cycle
  • Leucovorin 400 mg/m^2 given on Day 1 of a 2-week cycle
  • 5-FU 400 mg/m^2 bolus given on Day 1 of a 2 week cycle
  • 5-FU 2400 mg/m^2 continuous given over 46 - 48 hours on Day 1 of a 2-week cycle
  • Placebo given on day 1 of 2 week cycle

Participants will receive study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Drug: Placebo
Administered intravenously
Drug: Oxaliplatin
Administered intravenously
Drug: Leucovorin
Administered intravenously
Drug: 5-Fluorouracil
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic confirmation of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach
  • Metastatic or locally advanced, unresectable disease at time of study entry
  • Provided signed informed consent and is amenable to compliance with protocol schedules and testing
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry
  • Adequate renal, hematological, and hepatic function
  • Measurable or non-measurable disease at the time of study entry
  • Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy, except where otherwise mentioned in the eligibility criteria
  • Eligible participants of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
  • Life expectancy of greater than or equal to 3 months
  • Willingness to provide blood and tissue samples for research purposes. Submission of tumor specimen is mandatory for participation in this study, if a histologic, paraffin-embedded specimen exists (either from a surgical resection or biopsy); submission of paraffin block or a minimum of 8 unstained slides is required if sufficient sample. NOTE: If insufficient additional tissue exists (that is, all tissue has been utilized for prior diagnostic purposes), participation in the study is allowable without the requirement for an additional biopsy; this situation must be discussed with the study principal investigator and/or the ImClone medical monitor or designee

Exclusion Criteria:

  • The participant has received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neo- adjuvant therapy is permitted)
  • Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant ineligible for entry into this study
  • The participant is receiving chronic therapy with nonsteroidal anti- inflammatory agents (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted
  • The participant has significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage
  • The participant is pregnant or breastfeeding
  • Uncontrolled intercurrent illness including, but not limited to, active or uncontrolled clinically serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled thromboembolic, or hemorrhagic disorder, psychiatric illness/social situations, or other co-morbid systemic illnesses, or other severe concurrent disease
  • Immunocompromised participants including participants known to be human immunodeficiency virus (HIV) positive.
  • Progressive disease less than or equal to 12 months of completing platinum or 5-FU treatment, including capecitabine, if given previously in the perioperative (adjuvant or neoadjuvant) setting
  • Current or recent (within 28 days prior to randomization) treatment with an investigational drug that has not received regulatory approval for any indication at the time of study entry, or participation in another interventional clinical trial. Participants participating in surveys or observational studies are eligible to participate in this study.
  • Are currently enrolled in, or discontinued from, a clinical trial involving ramucirumab drug product (DP), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Received prior therapy with an antiangiogenic agent (including but not limited to bevacizumab, sunitinib, or sorafenib)
  • Major surgical procedure or significant traumatic injury greater less 28 days prior to registration, or anticipation of need for elective or planned major surgical procedure during the course of the study. Subcutaneous venous access device placement within 7 days prior to randomization
  • Clinically significant peripheral neuropathy at the time of registration
  • Known central nervous system metastases that are symptomatic or untreated
  • New York Heart Association (NYHA) classification III-IV congestive heart failure
  • Greater than normal risk of bleeding or coagulopathy in the absence of therapeutic anticoagulation; Grade 3/4 gastrointestinal bleeding within 3 months prior to registration; active bleeding (that is, within 14 days prior to first dose of study therapy); or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
  • Participant has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, stroke, transient ischemic attack (TIA), cerebrovascular accident, or unstable angina, less than or equal to 6 months prior to registration
  • Clinically significant vascular disease (for example, aortic aneurysm, aortic dissection) for which more than minimal intervention is being administered or planned
  • History of hypertensive crisis or hypertensive encephalopathy or current poorly-controlled hypertension despite standard medical management.
  • History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess great less than 6 months prior to registration.
  • Known hypersensitivity to any of the treatment components of modified FOLFOX6 (mFOLFOX6) (oxaliplatin, 5-fluorouracil, and leucovorin) or ramucirumab DP
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246960

  Show 58 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01246960     History of Changes
Other Study ID Numbers: 14057, I4T-MC-JVBT
Study First Received: November 8, 2010
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
cancer
stomach
esophagus
gastroesophageal

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2014