Preference Study With Elderly Patients Recurrent Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170690
• Other study ID #: 3401000
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 31, 2013
• Start date: August 2004
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Treosulfan
Treosulfan 600 mg/m² p.o. on daý 1-28, 57-84, etc
• Treosulfan
Treosulfan 7000 mg/m² i.v. on day 1, 29, 57 etc

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of patient´s compliance in both arms defined as therapy break-offs		during study treatment	Yes
Secondary	Toxicity, overall survival, progression-free survival		during study treatment and follow-up	Yes