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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Endometrial Cancer, Uterine Cervical Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Occurrence of grade 4 neutropenia

Outcome Time Frame:

2.5 years

Safety Issue:

No

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

BGOG-ov5

NCT ID:

NCT01523678

Start Date:

February 2012

Completion Date:

January 2019

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • Uterine Cervical Cancer
  • 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
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Adenoma

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