uterine papillary serous cancer (upsc) trial

Conditions: Uterine Cancer

Summary: this study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. the researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.

trial objectives: * to assess the safety and efficacy of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of upsc. * to observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of upsc. * to assess the qol, overall survival and disease free survival. treatment surgery: total abdominal hysterectomy, bilateral salpingo-oophorectomy, +/- pelvic and aortic node sampling, omentectomy, peritoneal cytology. chemotherapy: chemotherapy commences at the surgeon's and the medical oncologist's discretion and the time between surgery and start of chemotherapy will be recorded. one treatment cycle consists of 3 weeks. paclitaxel and carboplatin will be administered as follows: day 1: * diphenhydramine 50 mg iv or po or phenergan 12.5 - 25 mg iv * cimetidine 300 mg or ranitidine 50 mg iv * dexamethasone 20 mg iv * paclitaxel 175 mg/m2 * carboplatin auc 6 day 22: repeat the cycle. this is day 1 of the second cycle. day 43: repeat the cycle. this is day 1 of the third cycle. day 64: repeat the cycle. this is day 1 of the fourth cycle. day 85: after the fourth cycle of chemotherapy patients patients with stage 4 disease will continue with chemotherapy for a total of 6 cycles. patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 gy rd over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). radiotherapy will start 4 to 6 weeks after commencement of chemotherapy when the haematological count has recovered.

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.

Keywords: uterine papillary serous carcinoma (upsc)