Clinical trial NCT00147680: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Cancer
Keywords: Uterine Papillary Serous Carcinoma (UPSC)
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
First posted: 2005-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
measure: 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:
measure: To assess the quality of life (QOL), overall survival and disease free survival
Other outcomes:
Locations:
city: Herston
country: Australia
facility: QCGC, Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Public Hospital
state: Queensland
Study officials:
affiliation: QCGC
name: Andreas Obermair
role: PRINCIPAL_INVESTIGATOR
References: