Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
18 Years
N/A
Female
Ovarian Cancer
Trial Information
Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom
In Germany there are two established therapy regimes for platin sensitive ovarian cancer:
the combination of carboplatin and paclitaxel as well as the combination of carboplatin with
gemcitabine. Choice of therapy is individual due to missing randomized comparisons between
the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as
well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have
demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting
good efficacy and tolerability.
It shall be tested in this randomized phase III-study if the combination of topotecan and
carboplatin shows improvement of progression-free survival in comparison to the standard
regimes.
Inclusion Criteria:
- Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at
least six months after completion of primary standard therapy are eligible
- Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern
Co-operative Oncology Group (ECOG) performance status ≤ 2
- All patients will provide written informed consent
Exclusion Criteria:
- Patients with more than two chemotherapies in their history
- Progress less than six months after completion of primary standard therapy
- Simultaneous or planned radiation
- Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
- Patients with infection
- Patients who are pregnant or breast feeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progression-free survival
Outcome Time Frame:
after 1 year-follow-up
Safety Issue:
No
Principal Investigator
Jalid Sehouli
Investigator Role:
Study Chair
Investigator Affiliation:
Charité Campus Vichow Klinikum
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
3104000
NCT ID:
NCT00437307
Start Date:
March 2007
Completion Date:
September 2013
Related Keywords:
- Ovarian Cancer
- Ovarian Neoplasms
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