E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
recurrence of ovarian, fallopian tube or peritoneal carcinoma, cervical carcinoma or endometrial carcinoma |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008231 |
E.1.2 | Term | Cervical cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014736 |
E.1.2 | Term | Endometrial cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066697 |
E.1.2 | Term | Ovarian cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
*to evaluate occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF |
|
E.2.2 | Secondary objectives of the trial |
*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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Prevention of grade 4 neutropenia during chemotherapy |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Estimated 2,5 years after first patient, first visit |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-year and 5-year progression free survival and overall survival will be calculated |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 19 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
- all patients off treatment
- 5 years after last treatment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |