Status:
COMPLETED
Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
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
Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly i...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed ovarian adenocarcinoma
- Patients had to have received a front-line, platinum- based chemotherapy regimen
- Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
- Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
- A \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
- Age \> 18 years old
- 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 \> 9 gr/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 \< 2 mg/dl)
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00429559
Start Date
June 1 2006
End Date
July 1 2011
Last Update
July 22 2011
Active Locations (6)
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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