Uterine Papillary Serous Cancer (UPSC) Trial
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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) |
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 |
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| Australia, Queensland | |
| QCGC, Royal Brisbane and Women's Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Mater Adult Public Hospital | |
| South Brisbane, Queensland, Australia, 4101 | |
| 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 Uterine Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013