PHASE II TRIAL OF THE SEQUENTIAL ADMINISTRATION OF COMBINATIONS OF GEMCITABINE-CISPLATIN AND CARBOPLATIN-PACLITAXEL FOR THE TREATMENT OF PATIENTS WITH ADVANCED CARCINOMA OF THE OVARY WITH SUB-OPTIMAL CYTOREDUCTIO

• Conditions: 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.

• Registration Number: EUCTR2004-002473-23-ES
• Lead Sponsor: Dr. Amalia Velasco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-04
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 54

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 < 3 times greater than the normal range (both may be raised up to 5 times in excess of the normal value in patients with known hepatic metastases); and creatinine < 1.5 mg/dL.
9.Use of an appropriate contraceptive method during the trial and in the subsequent 3 months in those cases where pregnancy is possible.
10.Patients must be capable of ensuring adequate compliance with therapy and live sufficiently near to the treatment location to allow appropriate follow-up.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified