Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Belgian Gynaecological Oncology Group
ClinicalTrials.gov Identifier:
NCT01523678
First received: January 24, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Endometrial Cancer
Uterine Cervical Cancer
Drug: Filgrastim
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Belgian Gynaecological Oncology Group:

Primary Outcome Measures:
  • Occurrence of grade 4 neutropenia [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of other toxicities [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Occurence of dose reductions and dose delays [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 3 years, 7 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years, 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: February 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523678

Locations
Belgium
Cliniques du Sud-Luxembourg
Arlon, Belgium, 6700
Imeldaziekenhuis
Bonheiden, Belgium, 2820
AZ Klina
Brasschaat, Belgium, 2930
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
St. Maarten Duffel
Duffel, Belgium, 2570
UZ Antwerpen
Edegem, Belgium, 2650
Jan Yperman Ziekenhuis
Ieper, Belgium, 8900
AZ Groeninge
Kortrijk, Belgium, 8500
CHU Tivoli
La Louvière, Belgium, 7100
UZ Leuven
Leuven, Belgium, 3000
Centre Hospitalier de l'Ardenne
Libramont, Belgium, 6800
Centre Hospitalier Régional de la Citadelle
Liège, Belgium, 4000
CHU Sart Tilman Liège
Liège, Belgium, 4000
Cliniques et maternité St. Elizabeth
Namur, Belgium, 5000
AZ Damiaan
Oostende, Belgium, 8400
AZ Nikolaas
St. Niklaas, Belgium, 9100
Cliniques universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
Belgian Gynaecological Oncology Group
  More Information

Additional Information:
No publications provided

Responsible Party: Belgian Gynaecological Oncology Group
ClinicalTrials.gov Identifier: NCT01523678     History of Changes
Other Study ID Numbers: BGOG-ov5, 2010-022482-95
Study First Received: January 24, 2012
Last Updated: December 6, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Belgian Gynaecological Oncology Group:
Uterine Cervical Cancer
Ovarian Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Endocrine System Diseases
Endometrial Diseases
Uterine Cervical Diseases
Genital Diseases, Female
Ovarian Cancer
Endometrial Cancer
Endometrial Carcinoma
Paclitaxel
Carboplatin
Neupogen
Filgrastim
Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Endometrial
Cervical Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Carboplatin
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014