Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
18 Years
75 Years
Female
Ovarian Cancer
Trial Information
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.
Inclusion Criteria:
- Histologically- or cytologically- confirmed ovarian cancer requiring standard
chemotherapy
- Patients have to be chemotherapy naive
- Patients may have undergone cytoreductive surgery, or this may have been omitted due
to dissemination
- 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
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
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Safety Issue:
Yes
Principal Investigator
Christos Emmanouilides, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Authority:
Greece: National Organization of Medicines
Study ID:
CT/07.07
NCT ID:
NCT00750386
Start Date:
January 2008
Completion Date:
March 2011
Related Keywords:
- Ovarian Cancer
- Cancer
- Ovarian cancer
- Dose-dense chemotherapy
- Carcinoma
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
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