Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

This study has been completed.
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology Identifier:
First received: September 9, 2005
Last updated: March 24, 2016
Last verified: March 2016
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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progression-free survival [ Time Frame: every 3 cycle ] [ Designated as safety issue: No ]

Enrollment: 36
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00170625

Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: North Eastern Germany Society of Gynaecologic Oncology Identifier: NCT00170625     History of Changes
Other Study ID Numbers: 310300 
Study First Received: September 9, 2005
Last Updated: March 24, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on May 26, 2016