Uterine CancerPhase 2NCT00147680
Uterine Papillary Serous Cancer (UPSC) Trial
A Phase 2 study testing Paclitaxel, Carboplatin in people with Uterine Cancer, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cancer
- What is being tested?
- Paclitaxel, Carboplatin
- How many people
- 30 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2004to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Mater Adult Public Hospital
South Brisbane, Queensland, 4101
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Cancer
- Being tested
- Paclitaxel, Carboplatin
- Keywords
- Uterine Papillary Serous Carcinoma (UPSC)
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel, CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Investigators
- Andreas Obermair, Principal investigator, QCGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147680
- Sponsor's protocol ID
- UPSC - 001
- Status last verified
- Feb 2012
- First submitted
- 6 Sep 2005
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
- ClinicalTrials.gov ID
- NCT00147680
- Acronym / sponsor ID
- UPSC - 001
- Conditions
- Uterine Cancer
- Keywords
- Uterine Papillary Serous Carcinoma (UPSC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Study start
- Sep 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel, Carboplatin | Drug | – |
Primary outcome
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
1 secondary outcome
To assess the quality of life (QOL), overall survival and disease free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Obermair principal investigator
QCGC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Carboplatin in people with Uterine Cancer, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.