Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

NCT ID: NCT01523678

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-08-14

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

Conditions

Ovarian Cancer; Endometrial Cancer; Uterine Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Filgrastim

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Belgian Gynaecological Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliniques du Sud-Luxembourg

Arlon, , Belgium

Imeldaziekenhuis

Bonheiden, , Belgium

AZ Klina

Brasschaat, , Belgium

Grand Hôpital de Charleroi

Charleroi, , Belgium

St. Maarten Duffel

Duffel, , Belgium

UZ Antwerpen

Edegem, , Belgium

Jan Yperman Ziekenhuis

Ieper, , Belgium

AZ Groeninge

Kortrijk, , Belgium

CHU Tivoli

La Louvière, , Belgium

UZ Leuven

Leuven, , Belgium

Centre Hospitalier de l'Ardenne

Libramont, , Belgium

Centre Hospitalier Régional de la Citadelle

Liège, , Belgium

CHU Sart Tilman Liège

Liège, , Belgium

Cliniques et maternité St. Elizabeth

Namur, , Belgium

AZ Damiaan

Ostend, , Belgium

AZ Nikolaas

Sint-Niklaas, , Belgium

Cliniques universitaires UCL de Mont-Godinne

Yvoir, , Belgium

Countries

Belgium

Related Links

http://www.bgog.eu/

BGOG website

Other Identifiers

2010-022482-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BGOG-ov5

Identifier Type: -

Identifier Source: org_study_id