Ovarian Cancer
Conditions
Keywords
Cancer;, Ovarian cancer;, Recurrent ovarian cancer platinum-resistant
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 in patients with platinum -resistant ovarian cancer.
Interventions
DRUGHycamptin
1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression
DRUGGemcitabine
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
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan. | 1year |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity profile | 1 year |
Countries
Greece
Outcome results
None listed