Clinical trial · Interventional
Weekly Topotecan Therapy in Patients With Ovarian Cancer
A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
NCT00194935CI-TRIAL-00000443terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
Secondary outcomes (1)
- measure
- To determine the efficacy (Progression free survival) of weekly topotecan as consolidation therapy in ovarian cancer patients who are clinically NED or have microscopic disease only after first-line chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histopathologic diagnosis of epithelial ovarian cancer. * Patients must have completed front-line chemotherapy and be clinically NED (CA 125 \<35, negative CT scan, negative physical exam). * Patients may have a second look laparoscopy, however, there must be no gross disease present (microscopic disease or pathologically negative). * Patients must not have had other myelosuppressive therapy within four weeks of initiating topotecan therapy. * Topotecan treatment must begin within 10 weeks following last cycle of initial chemotherapy. * Patients may have had only one prior chemotherapy regimen. Exclusion Criteria: * Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer. * Patients who are pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.