Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
Inclusion Criteria:
All cohorts:
- Female subjects more than 18 years of age
- Performance status must be ECOG 0-2.
- Adequate organ function
- Measurable disease by RECIST version 1.1 or CA125 progression according to the GCIG
definition (Vergote et al).
- Written informed consent
Ovarian, fallopian tube or peritoneal carcinoma cohort:
- Histologically confirmed diagnosis of invasive epithelial ovarian,fallopian tube, or
peritoneal carcinoma (serous, mucinous, endometrioid,clear cell, or carcinosarcomas
are eligible).
- Patients should have received at least 1 earlier platin treatment but should be
platin refractory (progression within 28 days after the last dose of platin) or
platin resistant (progression within 6 months after last dose of platin therapy).
- Earlier weekly or dose-dense regimens with paclitaxel and carboplatin are not
allowed. Consolidation after the last platin dose with non-platinum containing
chemotherapy or molecular targeted drugs is allowed
Endometrial carcinoma cohort
- Histologically confirmed diagnosis of endometrial carcinoma
(endometrioid,adenoacanthoma, adenosquamous, serous, clear cell carcinoma or
carcinosarcomas are eligible).
- Recurrent or advanced endometrial carcinoma can be included.
- Earlier platin therapy is allowed. But earlier weekly or dose-dense regimens with
paclitaxel and carboplatin are not allowed.
Cervical carcinoma cohort
- Histologically confirmed diagnosis of cervical carcinoma (adenocarcinoma or squamous
carcinomas are eligible).
- Recurrent or advanced endometrial carcinoma can be included.
- Earlier platin (including concomitant with radiotherapy) therapy is allowed. But
earlier weekly or dose-dense regimens with paclitaxel and carboplatin are not
allowed.
Exclusion Criteria:
- Other histologies than those mentioned above such as non-epithelial ovarian
carcinomas, neuro-endocrine tumors, sarcomas, metastases from other primary tumors,
...
- Earlier weekly or dose-dense paclitaxel and carboplatin regimen.
- Any unstable or serious condition e.g. uncontrolled infection requiring systemic
therapy.
- Prior other malignancies treated primarily or for recurrence within 3 years prior to
inclusion in this study, except for completely resected non- melanomatous skin
carcinoma or successfully treated in situ carcinoma of the skin or cervix of the
uterus.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures
- Metastatic disease to the brain or leptomeninges.
- Treatment with any of the following anti-cancer therapies:
- radiation therapy, surgery or tumor embolization within 14 days prior to the first
dose of study chemotherapy.
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal
therapy within 14 days or five half-lives of a drug (whichever is longer) prior to
the first dose of study drug
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs similar
or related to Paclitaxel, Carboplatin or G-CSF.