Evaluating Afatinib for HER2-positive Uterine Serous Carcinoma
A Phase II Evaluation of Afatanib, an Irreversible Human Epidermal Growth Factor Receptor 2 (Her2/Neu) Tyrosine Kinase Inhibitor, in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
This study is testing if the drug Afatinib can help people with a specific type of uterine cancer that has high levels of HER2 and see how well it works for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy, Afatinib |
| Locations | 3 sites (Tucson, Arizona and 2 other locations) |
| Trial ID | NCT02491099 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed HER2-positive uterine serous carcinoma who have measurable disease and meet specific health criteria.
Not a fit: Patients with non-HER2-positive uterine serous carcinoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a challenging form of uterine cancer.
How similar studies have performed: Other studies have shown promising results with targeted therapies in HER2-positive cancers, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona and 2 other locations
- University of Arizona Cancer Center — Tucson, Arizona, United States (Completed)
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.