Uterine Papillary Serous Cancer (UPSC) Trial

February 1, 2012 updated by: Queensland Centre for Gynaecological Cancer

Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 175 mg/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 for 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • QCGC, Royal Brisbane and Women's Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queensland Centre for Gynaecological Cancer

Investigators

  • Principal Investigator: Andreas Obermair, QCGC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPSC - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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