Uterine Papillary Serous Cancer (UPSC) Trial

Uterine Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147680
• Other study ID #: UPSC - 001
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: February 1, 2012
• Start date: September 2004
• Est. completion date: October 2009

Study information

• Verified date: February 2012
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• Paclitaxel, Carboplatin

Locations

Country	Name	City	State
Australia	QCGC, Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Mater Adult Public Hospital	South Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
Primary	To observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of UPSC
Secondary	To assess the quality of life (QOL), overall survival and disease free survival