Back to resultsTherapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hycamtin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring platin-resistant
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hycamtin
Arm Description
Outcomes
Primary Outcome Measures
Toxicity
hematological adverse events and non-hematological adverse events grade 3/4
Secondary Outcome Measures
Progression-free Survival
progression-free survival according to kaplan-meier-estimator
Full Information
NCT ID
NCT00170625
First Posted
September 9, 2005
Last Updated
December 13, 2016
Sponsor
North Eastern German Society of Gynaecological Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00170625
Brief Title
Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
Official Title
Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Eastern German Society of Gynaecological Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compatibility of the topotecan therapy in combination with carboplatin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
platin-resistant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hycamtin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hycamtin
Intervention Description
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
Primary Outcome Measure Information:
Title
Toxicity
Description
hematological adverse events and non-hematological adverse events grade 3/4
Time Frame
after each cycle for up to one year
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
progression-free survival according to kaplan-meier-estimator
Time Frame
after every third cycle, for up to one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jalid Sehouli
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19427025
Citation
Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.
Results Reference
derived
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Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
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