Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
Dose dense chemotherapy has been proven beneficial in various oncological settings. It is
proposed that this concept be tested in ovarian cancer, with the support of growth factors.
It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.
- Histologically- or cytologically- confirmed ovarian cancer requiring standard
- Patients have to be chemotherapy naive
- Patients may have undergone cytoreductive surgery, or this may have been omitted due
- Age >18 years.
- Performance status (WHO) 0-2
- Life expectancy of at least three months.
- Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet
- 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
- Pregnant or nursing
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose and the response rate
Outcome Time Frame:
Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Christos Emmanouilides, MD
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Greece: National Organization of Medicines
- Ovarian Cancer
- Ovarian cancer
- Dose-dense chemotherapy
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial