This study will be a 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.

Condition	Intervention	Phase
Uterine Papillary Serous Carcinoma (UPSC)	Drug: Paclitaxel, Carboplatin	Phase II

Further Study Details: 

Primary Outcomes: • 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.
Secondary Outcomes: • To assess the QOL, overall survival and disease free survival.
Expected Total Enrollment:  30

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 175mg/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 to 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

Ages Eligible for Study:  18 Months and above,  Genders Eligible for Study:  Female

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 per cent. Patients with surgical stage 1a disease should not be enrolled.
• Females age >= 18 years old.
• 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 6months 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 CTC (Appendix 2). 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00147680

Andreas Obermair      +61 7 36368501    andreas_obermair@health.qld.gov.au
Dan Jackson      +61 7 3636 8522    dan_jackson@health.qld.gov.au

Australia, Queensland
      Mater Adult Public Hospital, South Brisbane,  Queensland,  4101,  Australia; Not yet recruiting
      QCGC, Royal Brisbane and Women''''s Hospital, HERSTON,  Queensland,  4029,  Australia; Recruiting

Study chairs or principal investigators

ANDREAS OBERMAIR,  Principal Investigator,  QCGC   

Study ID Numbers:  UPSC - 001
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147680
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-09-13