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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
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Präferenz-Studie Bei älteren Patientinnen Mit Ovarialkarzinomrezidiv: Treosulfan Oral vs. intravenös

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Comparison of patient´s compliance in both arms defined as therapy break-offs [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity, overall survival, progression-free survival [ Time Frame: during study treatment and follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 123
Study Start Date: August 2004
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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

Locations
Germany
Charité Campus Virchow-Klinikum
Berlin, Germany, 13533
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Investigators
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
  More Information

No publications provided

Responsible Party: W. Lichtenegger, Prof. Dr., Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin
ClinicalTrials.gov Identifier: NCT00170690     History of Changes
Other Study ID Numbers: 3401000
Study First Received: September 12, 2005
Last Updated: May 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013