Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Uterine Cervical Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genital Diseases, Female

Genital Neoplasms, Female

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Urogenital Neoplasms

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Genital Diseases

Peritoneal Diseases

Ovarian Diseases

Fallopian Tube Diseases

Endometrial Neoplasms

Endocrine Gland Neoplasms

Adnexal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Lenograstim

Tubulin Modulators

Antimitotic Agents

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.

Filgrastim

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.

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

Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

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

Belgian Gynaecological Oncology Group

Spots Global Cancer Trial Database for fallopian tube diseases