Nab-Paclitaxel and Carboplatin in Treating Patients with Recurrent Stage I-IV Endometrial Cancer
This phase II trial studies how well nab-paclitaxel and carboplatin work in treating patients with stage I-IV endometrial cancer that has returned after a period of improvement. Drugs used in chemotherapy, such as nab-paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Inclusion Criteria
- Female patients must have high risk resected stage I or 2 disease (papillary serous, clear cell, carcinosarcoma histology or grade 3), advanced stage (III or IV, all histologies) or recurrent endometrial cancer (all histologies); patients do not need measurable disease and can enroll following surgery
- Patients may not have received prior cytotoxic chemotherapy; however, nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed; patients may have received prior radiation therapy (including whole pelvic or vaginal brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy must be discontinued at least 2 weeks prior to entry on this study
- If patients underwent surgery, and chemotherapy is indicated after surgery either as adjuvant or to treat residual disease, study treatment should be initiated within 8 weeks of surgery
- In patients who have received prior radiation, at least 4 weeks should have elapsed since the completion of radiation therapy involving the whole pelvis or over 50% of the spine; if vaginal brachytherapy is planned with chemotherapy, it should be done before or after completion of chemotherapy treatment
- Poorly differentiated histology, uterine papillary serous carcinoma, clear cell carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic component is epithelial (versus sarcomatous)
- Patients may have synchronous endometrial and ovarian cancer primaries
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
- Patients must understand and willingly sign an approved informed consent, and authorization permitting release of personal health information
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)
- Bilirubin =< 1.5 mg/dL
- Platelets >= 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
- Creatinine < 1.5 mg/dL is recommended; however, institutional norms are acceptable
- Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Exclusion Criteria
- Other prior malignancies within 3 years, except non-melanoma skin cancers and synchronous ovarian primaries
- Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial)
- Patients with concomitant medical illness such as serious uncontrolled infection, or uncontrolled angina, which in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient
- Patients who are pregnant or breastfeeding
- Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators
- Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a Left ventricular ejection fraction (LVEF) in the past 6 months is documented to be 50% or greater; patients who have had a LVEF (performed for any reason) that is less than 50% in the past 6 months are ineligible
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02744898.
PRIMARY OBJECTIVES:
I. The percent completion of 6 cycles of therapy on this protocol.
SECONDARY OBJECTIVES:
I. To determine percent progression free survival at 6, 12, 18, 24 months from onset of study treatment with carboplatin and nab-paclitaxel (abraxane) in patients with high-risk histologic subtypes, advanced, or recurrent endometrial cancer.
II. To determine objective response rates by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (in patients with measurable disease) at the above time points.
III. To evaluate the safety of treatment with carboplatin and abraxane in this patient population and determine the nature and degree of toxicities following treatment.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin IV over 3 hours on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorBhavana Pothuri
- Primary IDS15-01156
- Secondary IDsNCI-2016-01206, s15-01156
- ClinicalTrials.gov IDNCT02744898