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Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170625
First received: September 9, 2005
Last updated: December 13, 2016
Last verified: December 2016
September 9, 2005
December 13, 2016
June 2004
May 2010   (Final data collection date for primary outcome measure)
Toxicity [ Time Frame: after each cycle for up to one year ]
hematological adverse events and non-hematological adverse events grade 3/4
Not Provided
Complete list of historical versions of study NCT00170625 on ClinicalTrials.gov Archive Site
Progression-free Survival [ Time Frame: after every third cycle, for up to one year ]
progression-free survival according to kaplan-meier-estimator
Not Provided
Not Provided
Not Provided
 
Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer
Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer
Compatibility of the topotecan therapy in combination with carboplatin.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Hycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d
Experimental: Hycamtin
Intervention: Drug: Hycamtin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00170625
310300
No
Not Provided
Plan to Share IPD: No
North Eastern Germany Society of Gynaecologic Oncology
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany
North Eastern Germany Society of Gynaecologic Oncology
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP