Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
NCT ID: NCT00429559
Last Updated: 2011-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2006-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Hycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
Gemcitabine
Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
Number of cycles: until progression
Interventions
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Hycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
Gemcitabine
Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.
Number of cycles: until progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Hellenic Oncology Research Group
Principal Investigators
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Antonia Kalikaki, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dep of Medical Oncology
Locations
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University Hospital of Crete
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, , Greece
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, , Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, , Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, , Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, , Greece
Countries
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Other Identifiers
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CT/06.14
Identifier Type: -
Identifier Source: org_study_id
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