Status:
COMPLETED
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
Lead Sponsor:
Belgian Gynaecological Oncology Group
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2018
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01523678
Start Date
February 1 2012
End Date
August 14 2018
Last Update
July 10 2019
Active Locations (17)
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1
Cliniques du Sud-Luxembourg
Arlon, Belgium, 6700
2
Imeldaziekenhuis
Bonheiden, Belgium, 2820
3
AZ Klina
Brasschaat, Belgium, 2930
4
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000