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

Hellenic Oncology Research Group

Status and phase: Terminated; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Docetaxel; Drug: Liposomal doxorubicin; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00758732

CT/05.09

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

1

Experimental group

Description:

Docetaxel/carboplatin

Treatment:

Drug: Carboplatin

Drug: Docetaxel

Drug: Docetaxel

2

Experimental group

Description:

Docetaxel/Caelyx

Treatment:

Drug: Liposomal doxorubicin

Drug: Docetaxel

Drug: Docetaxel