Uterine Papillary Serous Cancer (UPSC) Trial

NCT00147680 | Completed Phase 2

• 1 other identifier: UPSC - 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Uterine Cancer

Keywords

Uterine Papillary Serous Carcinoma (UPSC)

Outcome Measures

Primary Outcomes (2)

• To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) 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 (1)

• To assess the quality of life (QOL), overall survival and disease free survival

Interventions

Paclitaxel, Carboplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead

Study Sites (2)

QCGC, Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Adult Public Hospital

South Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

CP protocol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Andreas Obermair

  QCGC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2009
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

AU (2)