Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma

Phase 2TerminatedNCT00758732

Hellenic Oncology Research Group34 enrolled

Overview

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months

The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

DocetaxelDRUG

Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

CarboplatinDRUG

Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

DocetaxelDRUG

Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed ovarian cancer * Stage IIIB/IV * Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval \> 6 months * Presence of two-dimensional measurable disease. * Life expectancy of more than 3 months. * Age ≥ 18 years. * Performance status (WHO) 0-2 * Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3) * Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl) * Informed consent Exclusion Criteria: * Pregnant or nursing * Psychiatric illness or social situation that would preclude study compliance' * Other concurrent uncontrolled illness * Other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Other concurrent investigational agents

Locations (12)

University Hospital of Crete

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

"IASO" General Hospital of Athnes, Dep of Medical Oncology

Outcomes

Primary Outcomes

Overall Response Rate

Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes

Toxicity profile

Time frame: Toxicity assessment on each cycle

Time to tumor progression

Time frame: 1 year

Overall Survival

Time frame: 1 year

Data from ClinicalTrials.gov

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