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


Phase 2
18 Years
N/A
Not Enrolling
Female
Uterine Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC

Principal Investigator

Andreas Obermair

Investigator Role:

Principal Investigator

Investigator Affiliation:

QCGC

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

UPSC - 001

NCT ID:

NCT00147680

Start Date:

September 2004

Completion Date:

October 2009

Related Keywords:

  • Uterine Cancer
  • Uterine Papillary Serous Carcinoma (UPSC)
  • Uterine Neoplasms

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