Uterine Papillary Serous Cancer (UPSC) Trial

This study has been completed.
Sponsor:
Information provided by:
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00147680
First received: September 6, 2005
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Uterine Cancer
Drug: Paclitaxel, Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer

Resource links provided by NLM:


Further study details as provided by Queensland Centre for Gynaecological Cancer:

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

Estimated Enrollment: 30
Study Start Date: September 2004
Study Completion Date: October 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147680

Locations
Australia, Queensland
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Public Hospital
South Brisbane, Queensland, Australia, 4101
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
Investigators
Principal Investigator: Andreas Obermair QCGC
  More Information

No publications provided

Responsible Party: Prof Andreas Obermair, Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00147680     History of Changes
Other Study ID Numbers: UPSC - 001
Study First Received: September 6, 2005
Last Updated: February 1, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Queensland Centre for Gynaecological Cancer:
Uterine Papillary Serous Carcinoma (UPSC)

Additional relevant MeSH terms:
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014