The Phase II trial will be performed on a population of patients with a histological or cytological diagnosis of ovarian cancer (any histological type), at stages IIIB, IIIC, IV or primary peritoneal carcinoma. In both cases, the patients must present sub-optimal residual disease (> 1 cm), following surgical cytoreduction.
Conditions
Interventions
Trade Name: GEMZAR
Product Name: Gemcitabine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gemzar 1gr.
CAS Number: 150399-23-8
Other descriptive name: Gemcitabine (HCL)
Concentratio
Sponsors
Dr. Amalia Velasco
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of epithelial carcinoma of the ovaries, of any histological type, in FIGO stage IIIB, IIIC, IV, or primary peritoneal carcinoma, with sub-optimal residual disease (> 1 cm). In all patients, an attempt must be made at surgical cytoreduction and there must be a histological or cytological confirmation of the tumour. In patients with pleural effusion, a diagnostic thoracentesis with cytological study of the pleural fluid. No more than 12 weeks must have passed since first surgery or diagnosis of the tumour. 2. Patients must present measurable disease taking into account RECIST criteria, or demonstrated disease if in addition they `present raised levels of tumour marker (Ca 125). 3. Patients must not have received any prior chemotherapy treatment for their condition. 4. Functional status from 0-2 on the ECOG scale. 5. Life expectancy greater than 12 weeks. 6. Age equal to or greater than 18 years. 7. Adequate marrow reserve, defined as haemoglobin = 10 g/dL, platelets = 100,000/mm3 and absolute granulocyte count = 1,500/mm3. 8. Adequate hepatic and renal function, defined as: bilirubin ? 1.5 times above the normal value; GOT and GPT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Borderline ovarian tumours. 2. Severe uncontrolled active infection, according to the researcher’s criteria. 3. Pregnancy or period of breastfeeding. 4. Severe neuropathy degree ? 2. 5. Presence of severe arrhythmias requiring medical treatment. 6. Any serious concomitant disease in the investigator’s opinion. 7. Prior treatment with chemotherapy or radiation therapy for any reason. 8. Prior participation in any other protocol for the investigation of experimental medications during the 30 days prior to recruitment of the patient. 9. Prior diagnosis of malignant disease (except appropriately treated carcinoma of the cervix in situ or non-melanoma skin carcinoma). 10. Patient only with raised tumour marker (Ca 125) without demonstrable disease by any other means.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To study the percentage of complete clinical responses after the sequential administration of both combinations in patients qualifying for evaluation in the study.;Secondary Objective: • To study the toxicity in the administration of both combinations as well as with their sequential administration. • To study the percentage of complete clinical responses following administration of the first treatment sequence (gemcitabine-cisplatin) • To study the percentage of complete clinical responses to the regime administered after the first sequence and on conclusion of treatment. ;Primary end point(s): The principal variable to be assessed is the percentage of complete clinical responses (measured by RECIST criteria and tumour marker) following the sequential administration of both combinations. | — |
Countries
Spain
Outcome results
None listed