Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
2 other identifiers
interventional
108
1 country
17
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Feb 2012
Longer than P75 for phase_2 ovarian-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2018
CompletedJuly 10, 2019
July 1, 2019
2.2 years
January 24, 2012
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of grade 4 neutropenia
2.5 years
Secondary Outcomes (4)
Occurence of other toxicities
2.5 years
Occurence of dose reductions and dose delays
2.5 years
Progression free survival
3 years, 7 years
Overall survival
3 years, 7 years
Study Arms (1)
Filgrastim
EXPERIMENTALInterventions
All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Cliniques du Sud-Luxembourg
Arlon, 6700, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ Klina
Brasschaat, 2930, Belgium
Grand Hôpital de Charleroi
Charleroi, 6000, Belgium
St. Maarten Duffel
Duffel, 2570, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Jan Yperman Ziekenhuis
Ieper, 8900, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU Tivoli
La Louvière, 7100, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier de l'Ardenne
Libramont, 6800, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, 4000, Belgium
CHU Sart Tilman Liège
Liège, 4000, Belgium
Cliniques et maternité St. Elizabeth
Namur, 5000, Belgium
AZ Damiaan
Ostend, 8400, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
Cliniques universitaires UCL de Mont-Godinne
Yvoir, 5530, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2012
First Posted
February 1, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2014
Study Completion
August 14, 2018
Last Updated
July 10, 2019
Record last verified: 2019-07