Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of CR and PR in each arm

Outcome Time Frame:

every 12 weeks

Safety Issue:


Principal Investigator

Werner Lichtenegger

Investigator Role:

Study Chair

Investigator Affiliation:

Charité Campus Virchow Klinikum


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

September 2005

Completion Date:

February 2011

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms