Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

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

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.