None listed
Conditions
Brief summary
This study will be an open, non-randomised, clinical phase 2 trial which will involve 30 women diagnosed with Uterine Serous Papillary Cancer. We 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 safety and efficacy of treatment, and patterns of recurrence.
Interventions
Drug: Paclitaxel, Carboplatin
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: Premedications* including:
Diphenhydramine 50 mg IV o
Drug: Paclitaxel, Carboplatin 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: Premedications* including: 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 175mg/m2 Carboplatin Area Under Curve (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 with stage 4 disease will continue with chemotherapy to a total of 6 cycles Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy Recommended Dose (RD) over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 weeks after commencement of chemotherapy and when the haematological count has recovered *A patient's premedications can be reduced to diphenhydramine 25 mg/ phenergan 6.25mg and dexamethasone 10 mg or lower after the observation that the patient did not have any allergic reaction to the first and second doses of Paclitaxel.
Sponsors
Queensland Centre for Gynaecological Cancer
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with histologically confirmed Uterine Papillary Serous Carcinoma (UPSC) at surgical stage 1b to 4 disease. The serous-papillary component of the specimen must be at least 30 per cent. Patinets with surgical stage 1a disease should not be enrolled. Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2. 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 proceeding 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. 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.
Outcome results
None listed