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Trial record 4 of 5 for:    "Esophagus Adenocarcinoma" | "Trastuzumab"

PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression

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ClinicalTrials.gov Identifier: NCT02213289
Recruitment Status : Recruiting
First Posted : August 11, 2014
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Drug: Trastuzumab Drug: ABT-806 Drug: TBD2 Drug: Ramucirumab Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression
Actual Study Start Date : January 20, 2015
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2022

Arm Intervention/treatment
Experimental: HER2 Group
Trastuzumab
Drug: Trastuzumab
HER2 Group: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) + Trastuzumab
Other Name: Herceptin®

Experimental: MET group
Experimental: EGFR Arm
ABT-806
Drug: ABT-806
EGFR Group: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)+ ABT-806

Experimental: FGFR2 Arm
TBD2
Drug: TBD2
FGFR2 Group: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)+ TBD2

Experimental: VEGFR2 Arm
Ramucirumab
Drug: Ramucirumab
VEGFR2 Group: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)+ Ramucirumab
Other Name: Cyramza

Experimental: MSI-H Arm
Nivolumab
Drug: Nivolumab
MSI-H Group: FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)+ Nivolumab
Other Name: Opdivo




Primary Outcome Measures :
  1. Median Overall Survival [ Time Frame: Improve from 12 Months to 18 months ]
    To determine the median overall survival (mOS) of the combined HER2+, EGFR+, MSI-H, and VEGFR2+ groups treated with trastuzumab and rilotumumab, respectively, with each line of cytotoxic chemotherapy (up to three lines, Biologic Beyond Progression), compared to historical controls having an aggregate mOS of approximately 12 months.


Secondary Outcome Measures :
  1. Safety and Feasibility of Baseline Biopsies [ Time Frame: 12 Months ]
    Number of participants with adverse events of the total undergoing baseline biopsy of a metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis) as a measure of safety and tolerability

  2. Safety and Feasibility of Conducting Serial Biopsies [ Time Frame: 12 Months ]
    Number of participants with adverse events of the total undergoing serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis) as a measure of safety and tolerability


Other Outcome Measures:
  1. Median Overall Survival Comparison [ Time Frame: 12 Months ]
    To determine the median overall survival (mOS) collectively of all patients undergoing tumor molecular profiling with classification into one of six predefined gastroesophageal cancer (GEC) 'oncogenic driver' categories (HER2+, MET+, FGFR2+, VEGFR2+,MSI-H, and EGFR+) with paired specific targeted therapy via the biomarker assessment and treatment algorithm, along with standard chemotherapy (up to 3 lines), compared to historical controls having an aggregate mOS of approximately 12 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma
  2. Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery

    • >6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy)
    • No prior treatment with any targeted agent
    • Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening.
  3. Measurable metastatic disease by RECIST criteria,

    • Must be amenable to ultrasound or CT-guided biopsy of one metastatic lesion
    • Peritoneal disease as the sole site of occult metastasis or presenting as malignant ascites is acceptable if a cell block of tumor cells can be obtained showing >20% viable tumor cells.
  4. ECOG PS 0,1
  5. Age > 18 years
  6. Patients must have normal organ and marrow function as defined below:

    • granulocytes >1,2500/mcL
    • platelets >100,000/mcL
    • total bilirubin < 1.5 x ULN, <1.8 x ULN with liver metastases
    • AST(SGOT)/ALT(SGPT) <2.5 X ULN without liver metastases; <5 X ULN with liver metastases
    • creatinine within normal institutional limits (<1.5) OR
    • creatinine clearance >50 mL/min/1.73m2, (for creatinine level above normal)
    • INR: < 1.5 (patients on warfarin need to be converted to LMWH during study participation to be eligible)
  7. Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative studies.

    • Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies

  8. Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed PANGEA treatment with first, second and third line therapy as tolerated.
  9. Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form.
  10. If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than:

    Epirubicin < 720 mg/m2 Doxorubicin or liposomal doxorubicin < 360 mg/m2 Mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 If more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.

  11. Cardiac Ejection Fraction >50% (for HER2+ patients) as assessed by echocardiogram, MUGA scan, or cardiac MRI
  12. Willingness to use effective and reliable methods of contraception (For appropriate methods of contraception considered acceptable see Appendix B).

Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

  1. No CVA within 6 months, no recent MI within 6 months
  2. No currently active second malignancy
  3. No uncontrolled intercurrent illness or infection
  4. No peripheral edema > grade 2 at baseline.
  5. No peripheral neuropathy > grade 2 at baseline.
  6. No diarrhea > grade 2 at baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213289


Contacts
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Contact: Daniel Catenacci, M.D. dcatenac@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Daniel Catenacci, MD       dcatenac@bsd.uchicago.edu   
Principal Investigator: Daniel Catenacci, MD         
Sub-Investigator: Hedy Kindler, MD         
Sub-Investigator: Victoria Villaflor, MD         
Sponsors and Collaborators
University of Chicago
AbbVie
Investigators
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Principal Investigator: Daniel Catenacci, MD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02213289     History of Changes
Other Study ID Numbers: IRB14-0141
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Keywords provided by University of Chicago:
Gastric
Esophagogastric
Additional relevant MeSH terms:
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Trastuzumab
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nivolumab
Ramucirumab
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents