Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly
paclitaxel/carboplatin regimen in gynaecological cancers.
Purpose: This multicenter phase II trial is studying the side effects of weekly
paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent
epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or
cervical carcinoma. Data obtained in this trial will be compared with historical data as
published earlier.
The trial will include 3 cohorts of 36 patients:
- Subjects with ovarian, fallopian tube or peritoneal carcinoma
- Subjects with endometrial cancer
- Subjects with cervical carcinoma
Treatment:
Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously
weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and
possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of
chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2
years and then if clinically indicated. Subjects who develop disease progression will
discontinue therapy. Subjects who have no evidence of disease progression after completion of
study therapy will be followed until disease progression, withdrawal of informed consent, or
death.
Primary objective:
- To evaluate the occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with
prophylactic G-CSF
Secondary objectives:
- To evaluate per cohort the occurrence of grade 4 neutropenia
- To evaluate other toxicities
- To evaluate the dose reductions or dose delays in the chemotherapy
- To determine the progression free survival according to RECIST v1.1
- To evaluate the response rate and overall survival
;
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