Ovarian Carcinoma (MedDRA 6.1, PT:10033128), Primary Peritoneal Carcinoma (MedDRA 6.1, PT:10052171) and Fallopian Tube Cancer (MedDRA 6.1, PT:10016180), MedDRA version: 6.1 Level: PT Classification code 10033128
Conditions
Interventions
Trade Name: GEMZAR
Product Name: GEMZAR
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
Concentration unit: g gram(s)
Concentration type: equal
Concentration num
Sponsors
Grupo Español de Investigación en Cáncer de Ovario (GEICO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Recurrent ovarian epithelial cancer, primary peritoneal carcinoma or fallopian tube cancer histologically tested and previously treated. •Maximum 2 lines of previous treatment. •The last line of treatment received by the patient should include a platinum compound (cisplatin or carboplatin) and meet the sensitive-platinum criteria according to Thigpen´s definition (Platinum-sensitive patients are those who obtain an initial response to a platinum treatment and present a platinum-free interval > 6 months. We consider platinum-free interval treatment the time elapsed since the last cycle with platinum and the recurrent or progression date). •Patients should have received a taxane (docetaxel or paclitaxel) in any of the prior treatment lines. •Presence of unidimensionally measurable and/or valuable illness according to Rustin´s CA-125 response criteria (see 8.b.1.1. clinical response valuation). •Patients older than 18 years •Functional performance status or = 40 ml/min - Bilirubin no greater than 1,5 times upper limit of normal (ULN) - SGOT no greater than 2,5 times ULN (In case of metastases no greater than 5 times upper limit of normal). - Prothrombin time test> 50% - Hemoglobin > 10 mg/dL - Platelets > 100.000 / mm3 - Neutrophils > 2000 / mm3 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: •Patients with recurrent ovarian cancer considered platinum-resistant according to Thipgen´s criteria (progression, with no response with platinum-based drug treatment or recurrence within 6 months after a platinum treatment). •Patients who have received more than two lines of prior treatments. •Patients who have not received a platinum compound drug during the last chemotherapy line. •Patients who have not received a prior taxane therapy. •Patients who have received prior gemcitabine treatment. •Non-measurable or valuable illness according to Rustin´s criteria. •Active infection or another serious medical condition that in investigator´s opinion could interfere with the study´s development. •Central nervous system metastases. •Patients who does not present an adequate hepatic, renal or haematological function according to the previously defined criteria. •Patients with a history of another neoplasia except carcinoma in situ of the cervix properly treated, or basal cell carcinoma properly treated. •Pregnant women, nursing mothers or women of childbearing potential not practicing adequate means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical response rate of a standard carboplatin-paclitaxel combination versus a sequential combination of gemcitabine-carboplatin and paclitaxel-carboplatin in platinum-sensitive patients, with recurrent ovarian carcinoma, primary peritoneal carcinoma or fallopian tube cancer,who have received a prior taxane treatment and a platinum compound. ;Secondary Objective: 1.To determine progression-free survival and duration of response. 2.To determine the toxicity of both therapies. 3.Quality of life analysis. 4.Global survival.;Primary end point(s): The primary endpoint for evaluation of this trial is the percentage of clinical responses (by using RECIST and CA-125 response criteria) after the administration of both ways of treatment. | — |
Countries
Spain
Outcome results
None listed