Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-Resistant Ovarian Cancer

Condition(s) targeted: Ovarian Cancer

Intervention: Topotecan (Drug); Topotecan (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: North Eastern Germany Society of Gynaecologic Oncology

Official(s) and/or principal investigator(s):
Werner Lichtenegger, Study Chair, Affiliation: Charité Campus Virchow Klinikum

Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Rate of CR and PR in each arm

Secondary outcome:

Toxicity of topotecan treatment

Progression-free survival of both arms

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Charité Campus Virchow-Klinikum, Berlin 13533, Germany

Starting date: September 2005
Last updated: April 25, 2008