NCT01246960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Geographic Reach
1 country

58 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 8, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

November 8, 2010

Results QC Date

October 3, 2014

Last Update Submit

October 3, 2014

Conditions

Stomach CancerEsophageal Cancer

Keywords

cancerstomachesophagusgastroesophageal

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    PFS was defined using Response Evaluation Criteria in Solid Tumors \[RECIST version (v.) 1.1\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.

    Randomization to measured PD or date of death from any cause (up to Month 25.0)

Secondary Outcomes (5)

  • Overall Survival (OS)

    Randomization to date of death from any cause (up to Month 28.3)

  • Percentage of Participants Achieving an Objective Response (Objective Response Rate)

    Randomization to measured PD (up to Month 23.0)

  • Duration of Response

    Time of first response to measured PD (up to Month 23.0)

  • Time to Disease Progression (TTP)

    Randomization to measured PD (up to Month 25.0)

  • Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

    Months 1, 2, 4, 6, and 8

Other Outcomes (1)

  • Number of Participants With Adverse Events (AEs)

    Baseline through study completion (up to Month 28.3)

Study Arms (2)

Ramucirumab

EXPERIMENTAL

* 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 continuously given 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: RamucirumabDrug: OxaliplatinDrug: LeucovorinDrug: 5-Fluorouracil

Placebo

PLACEBO COMPARATOR

* 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 continuously given over 46-48 hours on Day 1 of a 2-week cycle * Placebo 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

Drug: PlaceboDrug: OxaliplatinDrug: LeucovorinDrug: 5-Fluorouracil

Interventions

RamucirumabBIOLOGICAL

Administered intravenously

Also known as: LY3009806, IMC-1121B
Ramucirumab
PlaceboDRUG

Administered intravenously

Placebo
OxaliplatinDRUG

Administered intravenously

PlaceboRamucirumab
LeucovorinDRUG

Administered intravenously

PlaceboRamucirumab
5-FluorouracilDRUG

Administered intravenously

Also known as: 5-FU
PlaceboRamucirumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 within the last 28 days 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 less than 28 days prior to randomization, 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (58)

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Anchorage, Alaska, 99508, United States

Location

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Scottsdale, Arizona, 85259, United States

Location

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Alhambra, California, 91801, United States

Location

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Bakersfield, California, 93309, United States

Location

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Fullerton, California, 92835, United States

Location

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Los Angeles, California, 90024, United States

Location

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Northridge, California, 91325, United States

Location

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Redondo Beach, California, 90277, United States

Location

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Santa Barbara, California, 93105, United States

Location

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Santa Monica, California, 93454, United States

Location

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Denver, Colorado, 80218, United States

Location

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Grand Junction, Colorado, 81501, United States

Location

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Washington D.C., District of Columbia, 20007, United States

Location

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Englewood, Florida, 34223, United States

Location

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Pembroke Pines, Florida, 33028, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Terre Haute, Indiana, 47802, United States

Location

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Sioux City, Iowa, 51101, United States

Location

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Wichita, Kansas, 67214, United States

Location

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New Orleans, Louisiana, 70121, United States

Location

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Lewiston, Maine, 04240, United States

Location

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Baltimore, Maryland, 21201, United States

Location

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Burlington, Massachusetts, 01805, United States

Location

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Springfield, Massachusetts, 01107, United States

Location

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Ann Arbor, Michigan, 48106, United States

Location

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Detroit, Michigan, 48201, United States

Location

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Grand Rapids, Michigan, 49503, United States

Location

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Kalamazoo, Michigan, 49007, United States

Location

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Duluth, Minnesota, 55805, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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Saint Louis Park, Minnesota, 55416, United States

Location

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St Louis, Missouri, 63110, United States

Location

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Billings, Montana, 59101, United States

Location

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Bozeman, Montana, 59715, United States

Location

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Omaha, Nebraska, 68106, United States

Location

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Las Vegas, Nevada, 89169, United States

Location

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Hackensack, New Jersey, 07601, United States

Location

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The Bronx, New York, 10467, United States

Location

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Cincinnati, Ohio, 45242, United States

Location

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Dayton, Ohio, 45420, United States

Location

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Oklahoma City, Oklahoma, 73104, United States

Location

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Danville, Pennsylvania, 17822, United States

Location

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Dunmore, Pennsylvania, 18512, United States

Location

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Philadelphia, Pennsylvania, 19141, United States

Location

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Charleston, South Carolina, 29425, United States

Location

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Columbia, South Carolina, 29210, United States

Location

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Spartanburg, South Carolina, 29303, United States

Location

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Chattanooga, Tennessee, 37404, United States

Location

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Nashville, Tennessee, 37203, United States

Location

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Salt Lake City, Utah, 84112, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Kirkland, Washington, 98034, United States

Location

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Mount Vernon, Washington, 98273, United States

Location

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Seattle, Washington, 98112, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Wenatchee, Washington, 98801, United States

Location

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Madison, Wisconsin, 53792, United States

Location

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Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

  • Yoon HH, Bendell JC, Braiteh FS, Firdaus I, Philip PA, Cohn AL, Lewis N, Anderson DM, Arrowsmith E, Schwartz JD, Gao L, Hsu Y, Xu Y, Ferry D, Alberts SR, Wainberg ZA. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016 Dec;27(12):2196-2203. doi: 10.1093/annonc/mdw423. Epub 2016 Oct 20.

    PMID: 27765757DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsNeoplasms

Interventions

RamucirumabOxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 24, 2010

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

May 1, 2014

Last Updated

October 8, 2014

Results First Posted

October 8, 2014

Record last verified: 2014-10

Locations

US(58)