Ovarian CancerPhase 2NCT01523678
Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
A Phase 2 study testing Filgrastim, Paclitaxel and Carboplatin in people with Ovarian Cancer and Endometrial Cancer, run by Belgian Gynaecological Oncology Group at 17 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Uterine Cervical Cancer
- What is being tested?
- Filgrastim, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 17 sitesBelgium
- Study dates
- Feb 2012to 14 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Belgium17 sites
Cliniques du Sud-Luxembourg
Arlon, 6700
Imeldaziekenhuis
Bonheiden, 2820
AZ Klina
Brasschaat, 2930
Grand Hôpital de Charleroi
Charleroi, 6000
St. Maarten Duffel
Duffel, 2570
UZ Antwerpen
Edegem, 2650
Jan Yperman Ziekenhuis
Ieper, 8900
AZ Groeninge
Kortrijk, 8500
CHU Tivoli
La Louvière, 7100
UZ Leuven
Leuven, 3000
Centre Hospitalier de l'Ardenne
Libramont, 6800
Centre Hospitalier Régional de la Citadelle
Liège, 4000
CHU Sart Tilman Liège
Liège, 4000
Cliniques et maternité St. Elizabeth
Namur, 5000
AZ Damiaan
Ostend, 8400
AZ Nikolaas
Sint-Niklaas, 9100
Cliniques universitaires UCL de Mont-Godinne
Yvoir, 5530
About this study
Official title: Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
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.
Read more
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.
Read the 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 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
- Conditions
- Ovarian Cancer, Endometrial Cancer, Uterine Cervical Cancer
- Being tested
- Filgrastim, Paclitaxel, Carboplatin
- Keywords
- 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
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Diseases, Peritoneal Diseases, Fallopian Tube Diseases, Endocrine System Diseases, Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
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.
PaclitaxelDrug
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.
CarboplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Experimental | Not described Receives: Drug: Filgrastim; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of grade 4 neutropenia
Measured: 2.5 years
Secondary outcomes (4)
Occurence of other toxicities
Measured: 2.5 years
Occurence of dose reductions and dose delays
Measured: 2.5 years
Progression free survival
Measured: 3 years, 7 years
Overall survival
Measured: 3 years, 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belgian Gynaecological Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523678
- Sponsor's protocol ID
- BGOG-ov5
- Other IDs
- 2010-022482-95
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2012
- Last updated
- 10 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
- ClinicalTrials.gov ID
- NCT01523678
- Acronym / sponsor ID
- BGOG-ov5
- Conditions
- Ovarian Cancer, Endometrial Cancer, Uterine Cervical Cancer
- Keywords
- Ovarian Cancer, Endometrial Cancer, Endometrial Carcinoma, Uterine Cervical Cancer, Paclitaxel, Carboplatin, Neupogen, Filgrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Belgian Gynaecological Oncology GroupUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | Experimental | Drug: Filgrastim, Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgrastimAll 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. | Drug | Filgrastim |
| PaclitaxelAll 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. | Drug | Filgrastim |
| CarboplatinAll 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. | Drug | Filgrastim |
Primary outcome
Occurrence of grade 4 neutropenia
Time frame: 2.5 years
4 secondary outcomes
Occurence of other toxicities
Time frame: 2.5 years
Occurence of dose reductions and dose delays
Time frame: 2.5 years
Progression free survival
Time frame: 3 years, 7 years
Overall survival
Time frame: 3 years, 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- BGOG websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim, Paclitaxel and Carboplatin in people with Ovarian Cancer and Endometrial Cancer, run by Belgian Gynaecological Oncology Group at 17 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of grade 4 neutropenia (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.