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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00743431 |
The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.
Condition | Intervention |
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Ovarian Neoplasms |
Drug: Pegylated Lyposomal Doxorubicin |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and PPE. |
Enrollment: | 224 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Women with advanced ovarian cancer
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Drug: Pegylated Lyposomal Doxorubicin
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
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This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.
Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women with advanced ovarian cancer with:
previous platin/taxan therapy and documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum CA 125 according to Rustin et al.
Inclusion Criteria:
Women with advanced ovarian cancer with:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04085 |
Study First Received: | August 26, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00743431 |
Health Authority: | Austria: Agency for Health and Food Safety |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Doxorubicin Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Antibiotics, Antineoplastic Pharmacologic Actions Adnexal Diseases |