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

North Eastern German Society of Gynaecological Oncology

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Topotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT00170677

4401000

Details and patient eligibility

About

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

Full 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.

Enrollment: 194 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Topotecan

B

Experimental group

Treatment:

Drug: Topotecan