Preference Study With Elderly Patients Recurrent Ovarian Cancer

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. Identifier: NCT00170690
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 3, 2013
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Treosulfan Phase 3

Detailed Description:

Approximately 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 stage 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös
Study Start Date : August 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: 1
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
Drug: Treosulfan
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Experimental: 2
Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc
Drug: Treosulfan
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc

Primary Outcome Measures :
  1. Comparison of patient´s compliance in both arms defined as therapy break-offs [ Time Frame: during study treatment ]

Secondary Outcome Measures :
  1. Toxicity, overall survival, progression-free survival [ Time Frame: during study treatment and follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00170690

Charité Campus Virchow-Klinikum
Berlin, Germany, 13533
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany

Responsible Party: W. Lichtenegger, Prof. Dr., Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin Identifier: NCT00170690     History of Changes
Other Study ID Numbers: 3401000
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Myeloablative Agonists