This trial is active, not recruiting.

Condition ovarian cancer
Treatment topotecan
Phase phase 3
Sponsor North Eastern Germany Society of Gynaecologic Oncology
Start date March 2007
End date July 2013
Trial size 550 participants
Trial identifier NCT00437307, 3104000


Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.
topotecan Hycamtin
Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d
(No Intervention)
Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d.

Primary Outcomes

progression-free survival
time frame: after 1 year-follow-up

Secondary Outcomes

overall survival, efficacy and tolerability of the regimes and quality of life
time frame: during study and follow-up

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by North Eastern Germany Society of Gynaecologic Oncology.