Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523678
• Other study ID #: BGOG-ov5
• Secondary ID: 2010-022482-95
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: August 14, 2018

Study information

• Verified date: July 2019
• Source: Belgian Gynaecological Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 14, 2018
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	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	Oostende
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	Cliniques universitaires UCL de Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Belgian Gynaecological Oncology Group

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of grade 4 neutropenia		2.5 years
Secondary	Occurence of other toxicities		2.5 years
Secondary	Occurence of dose reductions and dose delays		2.5 years
Secondary	Progression free survival		3 years, 7 years
Secondary	Overall survival		3 years, 7 years

External Links

•   BGOG website