Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

This is an interventional prevention trial for Ovarian Cancer focused on measuring Ovarian Cancer, Endometrial Cancer, Endometrial Carcinoma, Uterine Cervical Cancer, Paclitaxel, Carboplatin, Neupogen, Filgrastim, Ovarian Diseases, Peritoneal Diseases, Fallopian Tube Diseases, Endocrine System Diseases, Endometrial Diseases, Uterine Cervical Diseases, Neoplasms, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Neoplasms, Endometrial, Cervical Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms, Antineoplastic Agents, Phytogenic, Genital Diseases, Female Read More

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.