Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

Sponsor

Belgian Gynaecological Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01523678

Collaborator

(none)

108

Enrollment

Locations

Arm

78.4

Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Endometrial Cancer Uterine Cervical Cancer	Drug: Filgrastim Drug: Paclitaxel Drug: Carboplatin	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Aug 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Filgrastim	Drug: Filgrastim 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. Drug: Paclitaxel 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. Drug: Carboplatin 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.

Arm

Intervention/Treatment

Experimental: Filgrastim

Drug: Filgrastim

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.

Drug: Paclitaxel

Drug: Carboplatin

Outcome Measures

Primary Outcome Measures

Occurrence of grade 4 neutropenia [2.5 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	St. Maarten Duffel	Duffel	Belgium	2570
6	UZ Antwerpen	Edegem	Belgium	2650
7	Jan Yperman Ziekenhuis	Ieper	Belgium	8900
8	AZ Groeninge	Kortrijk	Belgium	8500
9	CHU Tivoli	La Louvière	Belgium	7100
10	UZ Leuven	Leuven	Belgium	3000
11	Centre Hospitalier de l'Ardenne	Libramont	Belgium	6800
12	Centre Hospitalier Régional de la Citadelle	Liège	Belgium	4000
13	CHU Sart Tilman Liège	Liège	Belgium	4000
14	Cliniques et maternité St. Elizabeth	Namur	Belgium	5000
15	AZ Damiaan	Oostende	Belgium	8400
16	AZ Nikolaas	Sint-Niklaas	Belgium	9100
17	Cliniques universitaires UCL de Mont-Godinne	Yvoir	Belgium	5530