Status:
WITHDRAWN
Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
HER-2 Positive Gastric Cancer
Gastrooesophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators are doing this research program to find out if the investigational drug, afatinib which is a medication known to block the function of the ErbB2 protein might help standard chemother...
Detailed Description
Standard Procedures: Subjects are offered second line chemotherapy with paclitaxel 80 mg/m2 intravenous infusion over 60 minutes on days 1, 8, and 15 of a 28-day cycle until disease progression or in...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the intrathoracic esophagus, gastrointestinal junction or stomach.
- Tumor must be HER2 positive 3+ by immunohistochemistry or positive by Fluorescence in situ hybridization (FISH) analysis if 2+ by immunohistochemistry.
- Received and failed at least one prior cytotoxic chemotherapy regimen for advanced disease that included trastuzumab.
- Age greater than or equal to 18 years.
- At least one measurable lesion as defined by modified RECIST criteria.
- ECOG performance status less than or equal to 2.
- Life expectancy of at least 12 weeks.
- Normal organ and marrow function as defined.
- Able to swallow and retain oral medication.
- Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO).
- Prior malignancy is acceptable if the subject is considered to be cured.
- Ability to understand and the willingness to sign a written informed consent document.
- All subjects of childbearing potential must agree to use acceptable methods of birth control (Men and Women).
- Willingness to consent to the use of baseline diagnostic tumor specimen for correlative studies.
Exclusion
- Squamous cell carcinoma.
- History of clinically relevant cardiovascular abnormalities within 6 months.
- Baseline (less than 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50 percent measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram.
- Pregnant and lactating women are excluded from the study.
- Significant or recent acute gastrointestinal disorders with diarrhea.
- More than 2 prior cytotoxic chemotherapy regimens for relapsed or metastatic disease.
- Major surgery, chemotherapy, radiation therapy or other cancer therapy within 3 weeks of treatment day 1.
- Use of any investigational drug within 4 weeks.
- Prior treatment with taxanes if given as full-dose chemotherapy for advanced disease.
- Prior treatment with afatinib or any other HER2 inhibitor other than trastuzumab.
- Front-line chemotherapy that did not contain trastuzumab.
- Active central nervous system disease (CNS) metastases.
- Planned concurrent anti-cancer therapy while taking investigational treatment.
- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2).
- Peripheral neuropathy of Grade 2 or greater
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel
- Prior anthracycline therapy with a cumulative dose of doxorubicin (or equivalent) greater than or equal to 400 mg/m2
- Pre-existing or current interstitial lung disease
- Known Hypersensitivity to Afatinib (BIBW 2992) or the excipients of any of the trial drugs.
- Patients unable to comply with the protocol.
- Active hepatitis B infection, active hepatitis C infection or known human immunodeficiency virus HIV carrier.
- Known or suspected active drug or alcohol abuse.
- Concomitant treatment with strong inhibitors or inducers of P-glycoprotein.
Key Trial Info
Start Date :
May 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02274012
Start Date
May 29 2014
End Date
August 12 2015
Last Update
March 14 2017
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