Preference Study With Elderly Patients Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170690
First received: September 12, 2005
Last updated: May 31, 2013
Last verified: May 2013

September 12, 2005
May 31, 2013
August 2004
December 2011   (final data collection date for primary outcome measure)
Comparison of patient´s compliance in both arms defined as therapy break-offs [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00170690 on ClinicalTrials.gov Archive Site
Toxicity, overall survival, progression-free survival [ Time Frame: during study treatment and follow-up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Preference Study With Elderly Patients Recurrent Ovarian Cancer
Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Treosulfan
    Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
  • Drug: Treosulfan
    Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
  • Experimental: 1
    Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc
    Intervention: Drug: Treosulfan
  • Experimental: 2
    Treosulfan 600 mg/m² p.o. on day 1-28, 57-84, etc
    Intervention: Drug: Treosulfan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00170690
3401000
No
W. Lichtenegger, Prof. Dr., Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
North Eastern Germany Society of Gynaecologic Oncology
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP