A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease
18 Years
N/A
Female
Ovarian Cancer
Trial Information
A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate
Outcome Time Frame:
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Safety Issue:
No
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/05.09
NCT ID:
NCT00758732
Start Date:
October 2005
Completion Date:
March 2011
Related Keywords:
- Ovarian Cancer
- Cancer
- Ovarian cancer
- Chemotherapy
- Docetaxel
- Carboplatin
- Pegylated doxorubicin
- Platinum sensitive
- Ovarian Neoplasms
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