Ovarian cancer MedDRA version: 8.1 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer
Conditions
Interventions
Trade Name: GEMZAR*INFUS 1FL 1G POLV
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Histologically proven ovarian cancer with evidence of recurrence or progression, which is not amenable to curative surgery or radiotherapy 2 Failed first-line platinum-containing therapy after at least 6 months of platinum discontinuation even if the first-line therapy included maintenance treatment . The standard for first-line treatment in ovarian cancer chemotherapy is the combination of platin derivatives and paclitaxel. In this study, inclusion can be extended to patients not treated with this standard because a the standard was different at the time of first line therapy and the patient is not eligible for taxanes therapy, and/or b the patients had not been treated with standard chemotherapy for other reasons, such as toxicity. The patient must, however, be pre-treated with platinum. 3 Documented lesion as evidenced by appropriate computerized tomography CT , or magnetic resonance imaging MRI scan, chest x ray, or ultrasound. Physical examination is allowed for lymph nodes. A physical gynecological examination of well-defined palpable tumor lesions is also permitted. Patients must have evaluable disease outside of the previously irradiated area. 4 Previous radiotherapy must be terminated at least 3 weeks before study drug administration. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 11 Clinical evidence of central nervous system CNS metastases. 14 A second primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin . 17 Received more than one previous chemotherapy regimen or had prior gemcitabine treatment. 19 Patients with estimated GFR 50 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the myelotoxicity in patients treated with carboplatin plus gemcitabine according to a new schedule in which carboplatin is administered on day 2 of the cycle. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy at least 6 months after treatment discontinuation.;Secondary Objective: Response rate Time to progression;Primary end point(s): Objective tumor response, measured according to the RECIST criteria Therasse et al 2000 , will be used in this trial. Response rate will be used as a screen to warrant further testing. Its utilization is not encumbered by the implied assumption of therapeutic benefit of such responses but rather implies some degree of biological anti-tumor activity of this combination. | — |
Countries
Italy
Outcome results
None listed