Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

North Eastern German Society of Gynaecological Oncology

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00170664

020114

Details and patient eligibility

About

The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.

Enrollment: 129 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
• life expectancy of more than three months
• ECOG performance status less than 3
• laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl.
• written informed consent

Exclusion criteria

• suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
• radiotherapy within 4 weeks for study entry

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Paclitaxel, Carboplatin

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin