Status:
COMPLETED
Uterine Papillary Serous Cancer (UPSC) Trial
Lead Sponsor:
Queensland Centre for Gynaecological Cancer
Conditions:
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 cycl...
Detailed Description
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 follow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00147680
Start Date
September 1 2004
End Date
October 1 2009
Last Update
February 2 2012
Active Locations (2)
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1
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
2
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101