Ovarian Cancer
Conditions
Brief summary
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
Detailed description
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.
Interventions
DRUGTopotecan
Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.
Sponsors
North Eastern German Society of Gynaecological Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with histologically-confirmed ovarian cancer * relapse within 6 month after primary therapy * primary therapy with platin and taxan * ECOG 0-2 * \>= 18 years * leukocytes \>= 3.000/ µl * platelet \>= 100.000/ µl * neutrophil \>= 1.500/ µl * written informed consent
Exclusion criteria
* earlier topotecan therapy * simultaneous or planned radiotherapy * secondary malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of CR and PR in each arm | every 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity of topotecan treatment | after each cycle |
| Progression-free survival of both arms | every 12 weeks |
Countries
Germany
Outcome results
None listed