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Uterine Papillary Serous Cancer (UPSC) Trial

Primary Purpose

Uterine Cancer

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Paclitaxel, Carboplatin
Sponsored by
Queensland Centre for Gynaecological Cancer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cancer focused on measuring Uterine Papillary Serous Carcinoma (UPSC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • QCGC, Royal Brisbane and Women's Hospital
  • Mater Adult Public Hospital

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 6, 2005
Last Updated
February 1, 2012
Sponsor
Queensland Centre for Gynaecological Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT00147680
Brief Title
Uterine Papillary Serous Cancer (UPSC) Trial
Official Title
Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Queensland Centre for Gynaecological Cancer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cancer
Keywords
Uterine Papillary Serous Carcinoma (UPSC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Carboplatin
Primary Outcome Measure Information:
Title
To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
Title
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 Measure Information:
Title
To assess the quality of life (QOL), overall survival and disease free survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Obermair
Organizational Affiliation
QCGC
Official's Role
Principal Investigator
Facility Information:
Facility Name
QCGC, Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Adult Public Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia

12. IPD Sharing Statement

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Uterine Papillary Serous Cancer (UPSC) Trial

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