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

N

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)

194 participants in 2 patient groups

A
Active Comparator group
Treatment:
Drug: Topotecan
B
Experimental group
Treatment:
Drug: Topotecan

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems