Phase 2 N=26 Treatment

Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Ovarian Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00170625 ↗

Enrolled (actual)

Serious AEs

46.2%

Results posted

Feb 2017

Primary outcome: Primary: Occurrence of a DLT (Dose Limiting Toxicity) — 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hycamtin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: North Eastern German Society of Gynaecological Oncology
Primary completion: Aug 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of a DLT (Dose Limiting Toxicity)	0; 1	—
SECONDARY Progression-free Survival (PFS)	7.3; 8.4	—

Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Eligibility Criteria

Inclusion Criteria

Age >= 18 years
patient with ovarian cancer after primary therapy
bone marrow function leukocytes >= 4, 0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
renal function creatinin = 60 ml/min
liver function bilirubin 2
patients with radiotherapy within the last 4 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00170625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.