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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stomach Cancer, Esophageal Cancer

Thank you

Trial Information

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


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 patients 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 patient 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 patient ineligible for entry into
this study

- The patient 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 mg/day is permitted

- The patient has significant third-space fluid retention (for example, ascites or
pleural effusion), and is not amenable for required repeated drainage

- The patient 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 patients including patients known to be 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.
Patients 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 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)

- Patient 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 mFOLFOX6 or ramucirumab
DP

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Baseline until measured progressive disease or date of death from any cause

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

14057

NCT ID:

NCT01246960

Start Date:

April 2011

Completion Date:

May 2014

Related Keywords:

  • Stomach Cancer
  • Esophageal Cancer
  • cancer
  • stomach
  • esophagus
  • gastroesophageal
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Iowa City, Iowa  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Manhassaet, New York  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Indianapolis, Indiana  46227
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Overland Park, Kansas  66210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Metairie, Louisiana  70006
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bethesda, Maryland  20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Kalamazoo, Michigan  49048
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Minneapolis, Minnesota  55404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Billings, Montana  59101
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Las Vegas, Nevada  89169
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cherry Hill, New Jersey  08003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cincinnati, Ohio  45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Tulsa, Oklahoma  74136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Dunmore, Pennsylvania  18512
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Salt Lake City, Utah  84106
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Norfolk, Virginia  23502
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Seattle, Washington  98133
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Marshfield, Wisconsin  54449
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Scarborough, Maine  04074
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Springfield, Massachusetts  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska  68114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Anchorage, Alaska  99508
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Washington, District of Columbia  20007