Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer
Overview
- Phase
- Phase 1
- Intervention
- Hycamtin
- Conditions
- Ovarian Cancer
- Sponsor
- North Eastern German Society of Gynaecological Oncology
- Enrollment
- 28
- Primary Endpoint
- Occurrence of a DLT (Dose Limiting Toxicity)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Compatibility of the topotecan therapy in combination with carboplatin.
Detailed Description
The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.
Investigators
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 \<= 1,5 mg% or creatinin clearance \>= 60 ml/min
- •liver function bilirubin \<= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
- •ECOG \<= 2
- •Intention of regular follow-up visits for the duration of the study
- •written informed consent
Exclusion Criteria
- •any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
- •ECOG \> 2
- •patients with radiotherapy within the last 4 weeks
Arms & Interventions
Relapse 6-12 months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Intervention: Hycamtin
Relapse >12 months
dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Intervention: Hycamtin
Outcomes
Primary Outcomes
Occurrence of a DLT (Dose Limiting Toxicity)
Time Frame: after each cycle for up to one year
A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.
Secondary Outcomes
- Progression-free Survival (PFS)(after every third cycle, for up to one year)