Clinical trial NCT01523678: Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers
Official title: Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Endometrial Cancer
Uterine Cervical Cancer
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
Cervical Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Antineoplastic Agents, Phytogenic
Genital Diseases, Female
Lead sponsor: Belgian Gynaecological Oncology Group
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of grade 4 neutropenia
timeFrame: 2.5 years
Secondary outcomes:
measure: Occurence of other toxicities
timeFrame: 2.5 years
measure: Occurence of dose reductions and dose delays
timeFrame: 2.5 years
measure: Progression free survival
timeFrame: 3 years, 7 years
measure: Overall survival
timeFrame: 3 years, 7 years
Other outcomes:
Locations:
city: Arlon
country: Belgium
facility: Cliniques du Sud-Luxembourg
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
city: Duffel
country: Belgium
facility: St. Maarten Duffel
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Leuven
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'Ardenne
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Liège
country: Belgium
facility: CHU Sart Tilman Liège
city: Namur
country: Belgium
facility: Cliniques et maternité St. Elizabeth
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Yvoir
country: Belgium
facility: Cliniques universitaires UCL de Mont-Godinne
Study officials:
References: