recurrence of ovarian, fallopian tube or peritoneal carcinoma, cervical carcinoma or endometrial carcinoma MedDRA version: 14.1 Level: LLT Classification code 10008231 Term: Cervical cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10014736 Term: Endometrial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedD
Conditions
Interventions
Trade Name: Neupogen
Product Name: Neupogen
Pharmaceutical Form: Solution for injection
Sponsors
Belgian Gynaecological Oncolgy Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ovarian, fallopian tube or peritoneal carcinoma cohort: *Female subjects more than 18 years old *Histologically confirmed diagnosis of invasive epithelial ovarian, fallopian tube or peritoneal carcinoma *All patients with at least 1 earlier platin treatment can be included but should be platin refracory or resistant. 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 isallowed *Performance status must be ECOG 0-2 *Adequate organ function *Measurable disease *Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow-up Endometrial cancer cohort: *Female subjects older than 18 years *Histologically confirmed diagnosis of endometrial carcinoma *Recurrent or advanced endometrial carcinoma can be included. Earlier pltin therapy is allowed. But earlier weekly or dose-dense regimens with paclitaxcel and carboplatin are not allowed *Performence status must be ECOG 0-2 *Adequate organ function *Measurable disease Cervical cancer cohort: *Female subjects more than 18 years old *Histologically confirmed diagnosis of cervical carcinoma *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. *Performance status must be ECOG 0-2 *Adequate organ function *Measurable disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
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 maglignancies 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 hte 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, immunotherpy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half -lives of a drug prior to the first dose of study drug *Known immediate or delayed hypersensistivity reaction or idiosyncrasy to drugs similar or related to Paclitaxel, carboplatin or G-CSF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: *to evaluate occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF;Secondary Objective: *To evaluate per cohort the occurence of grade 4 neutropenia *To evaluate other toxicity than neutropenia and dose reductions or delay *Determine the progression free survival according to the RECIST-criteria of the combination of weekly paclitaxel/carboplatin *to evaluate the response rate and overall survival;Primary end point(s): Prevention of grade 4 neutropenia during chemotherapy;Timepoint(s) of evaluation of this end point: Estimated 2,5 years after first patient, first visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate per cohort (ovarian, endometrial, cervical carcinoma) the occurrence of grade 4 neutropenia. To evaluate other toxicity than neutropenia (bone marrow, peripheral neuropathy, alopecia, ..) and dose reductions or delay. Determine the progression free survival according to the RECIST-criteria (Eisenhauer et al) of the combination of weekly paclitaxel/carboplatin To evaluate the response rate and overall survival.;Timepoint(s) of evaluation of this end point: 1-year and 5-year progression free survival and overall survival will be calculated | — |
Countries
Belgium
Outcome results
None listed