Status:
COMPLETED
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00750386
Start Date
January 1 2008
End Date
March 1 2011
Last Update
May 23 2011
Active Locations (12)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece