Uterine Papillary Serous Cancer (UPSC) Trial

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queensland Centre for Gynaecological Cancer
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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.