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Preference Study With Elderly Patients Recurrent Ovarian Cancer
This study is currently recruiting participants.
Verified by North Eastern Germany Society of Gynaecologic Oncology, February 2007
Sponsored by: North Eastern Germany Society of Gynaecologic Oncology
Information provided by: North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT00170690
  Purpose

Comparison of the patient compliance treosulfan oral vs. intravenous (defined as end of therapy for the patient)


Condition Intervention Phase
Ovarian Cancer
Drug: Treosulfan
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Treosulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Estimated Enrollment: 160
Study Start Date: August 2004
Estimated Study Completion Date: June 2013
Detailed Description:

Approx. 60% of all cancer diseases appear to people aged 65 years and older. Ovarian cancer is the most frequent cause of death among gynaecological malignant tumours. Since the highest carcinoma incidence is between the 60th and 70th year more women will come down with ovarian cancer because of increased life expectancy. At least 65% of patients with FIGO Dtage III/IV will exhibit a relapse or progress after first-line therapy. In most studies the age of the patients is limited to 65 years. It could be shown that especially elder patients often receive an inadequate operative and cytostatic therapy resulting in a worse prognosis.

Patients aged 70 years or elder who will be treated with treosulfan, given oral or intravenous, shall be compared regarding the patient compliance, toxicity especially hematological and gastrointestinal toxicity grade 3-4 (CTC NCI), overall survival, progression free survival, quality of life.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with relapsed ovarian cancer
  • study therapy of third regime
  • measurable or evaluable tumor lesions or progression defined as CA-125 more than >= 100 U/ ml.
  • Age >= 70 years
  • ECOG 0-2
  • written informed consent

Exclusion Criteria:

  • Pretreatment with treosulfan
  • patient without measurable or evaluable tumor lesions or CA-125 more than >= 100 U/ ml.
  • no adequate bone marrow function (leukocyte <= 2,9 x 109/l, platelets <= 100 x 109/ l
  • creatinin and bilirubin within >= 1,25 x fold of the reference laboratory´s normal range
  • simultaneous radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170690

Contacts
Contact: Werner Lichtenegger 030/ 450 564 052 studiensekretariat.agovarialca@charite.de

Locations
Germany
Charité Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13533
Contact: Werner Lichtenegger     030/ 450 640 52     studiensekretariat.agovarialca@charite.de    
Principal Investigator: Werner Lichtenegger            
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Investigators
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
  More Information

Study ID Numbers: 3401000
Study First Received: September 12, 2005
Last Updated: February 26, 2007
ClinicalTrials.gov Identifier: NCT00170690  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Treosulfan
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009