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Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170625
First Posted: September 15, 2005
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
  Purpose
Compatibility of the topotecan therapy in combination with carboplatin.

Condition Intervention Phase
Ovarian Cancer Drug: Hycamtin Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:
  • Toxicity [ Time Frame: after each cycle for up to one year ]
    hematological adverse events and non-hematological adverse events grade 3/4


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: after every third cycle, for up to one year ]
    progression-free survival according to kaplan-meier-estimator


Enrollment: 28
Study Start Date: June 2004
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hycamtin Drug: Hycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170625


Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Investigators
Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT00170625     History of Changes
Other Study ID Numbers: 310300
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: October 4, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
platin-resistant

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Topotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action