Uterine Papillary Serous Cancer (UPSC) Trial
Uterine Cancer
About this trial
This is an interventional treatment trial for Uterine Cancer focused on measuring Uterine Papillary Serous Carcinoma (UPSC)
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed UPSC at surgical stage 1b to 4 disease. The serous-papillary component of the specimen must be at least 30 percent. Patients with surgical stage 1a disease should not be enrolled. Females aged >= 18 years old. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Patients may not have received any prior chemotherapy regimens for UPSC. Patients must have adequate bone marrow, renal, hepatic and neurologic function. Patients must be informed of the investigational nature of the study and sign an informed consent form. Patients with previous malignancy are eligible only if the patient has been disease-free for >= 5 years. Exclusion Criteria: Patients with pre-existing >= grade 2 neurotoxicity. Patients with uncontrolled hypertension, (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg) or uncontrolled cardiac arrhythmia or diabetes mellitus Patients with a history of other malignancy within the last 5 years that could affect the diagnosis or assessment of UPSC. Patients who have a history of serious cardiac disease that is not adequately controlled are not allowed. Patients with documented myocardial infarction within 6 months preceding study entry; congestive heart failure; unstable angina; a clinically significant pericardial effusion; or arrhythmias are also ineligible. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Serious medical or psychiatric illnesses that would prevent informed consent. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. Patients with prior significant allergic reactions to drugs containing cremophor, such as cyclosporine, or vitamin K are not eligible. A significant reaction may be defined as, but is not limited to, the description of grade >= 3 allergic reactions using the Common Toxicity Criteria (CTC). Patients with known hypersensitivity to paclitaxel, carboplatin or Cremophor EL. Patients who have received prior whole pelvis radiotherapy. Patients with uncontrolled pelvic inflammatory disease that would contraindicate pelvic radiotherapy. Patients who are pregnant or breast-feeding. Patients receiving other investigational therapy.
Sites / Locations
- QCGC, Royal Brisbane and Women's Hospital
- Mater Adult Public Hospital