Evaluating Afatinib for HER2-positive Uterine Serous Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Afatinib in patients with persistent or recurrent uterine serous carcinoma that overexpresses HER2/neu. The primary goal is to determine the proportion of patients who remain progression-free for at least six months after starting treatment. Secondary objectives include assessing the overall response rate, disease control rate, and overall survival, as well as the safety profile of Afatinib. The study also aims to explore the correlation between HER2/neu expression and clinical outcomes, as well as the role of immune mechanisms in treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have persistent or recurrent histologically confirmed uterine serous carcinoma, harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH.
* Have measurable disease.
* Have at least one target lesion to be used to assess response as defined by RECIST v1.1.
* After undergoing surgery may be optimally or sub optimally debulked, with measurable recurrent disease of any previous substage.
* Diagnosis histologically confirmed by a gynecologic pathologist as containing \>10% uterine papillary serous adenocarcinoma in the specimen.
* Have adequate bone marrow function.
* WBC greater than or equal to 3,000/ul, platelets greater than or equal to 75,000/ul, neutrophils greater than or equal to 1500/ul., creatinine less than or equal to 2.0 mg/kl, bilirubin \< 1.5 X laboratory normal, SGOT/SGPT \<3 X laboratory normal.
* Have an ECOG performance status of 0 or 1.
* Have signed an approved consent.
* Have recovered from effects of recent surgery, radiotherapy or chemotherapy. Should be free of significant infection.
* Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer.
* May have received prior trastuzumab therapy alone or in combination with chemotherapy with 2 week washout period required between trastuzumab treatment and first dose of Afatanib.
* Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception.
* Must be 18 years of age.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. NOTE: Patients with prior anthracycline exposure are NOT eligible.

Exclusion Criteria:

* Patients who have a significant history of cardiac disease, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration. Patients with any unstable medical issue, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics, known brain/leptomengial involvement of the disease, active neurological disease, dementia.
* Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor.
* Patients who have an uncontrolled seizure disorder or active neurological disease. Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range. Known hemorrhagic diathesis or active bleeding disorder.

Where it's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Completed
• Massachusetts General Hospital
  Boston, Massachusetts, United States Completed

Study contacts

• Principal investigator: Alessandro Santin, M.D. — Yale University
• Study coordinator: Alessandro D. Santin, M.D.
• Email: alessandro.santin@yale.edu
• Phone: 203-737-4450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.