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Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00170625
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology

Brief Summary:
Compatibility of the topotecan therapy in combination with carboplatin.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Hycamtin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : June 2004
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010


Arm Intervention/treatment
Experimental: Hycamtin Drug: Hycamtin
Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d



Primary Outcome Measures :
  1. 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 :
  1. Progression-free Survival [ Time Frame: after every third cycle, for up to one year ]
    progression-free survival according to kaplan-meier-estimator



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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

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

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 Posted: September 15, 2005    Key Record Dates
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