Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
1 other identifier
observational
224
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
June 22, 2010
CompletedApril 15, 2015
March 1, 2015
3.8 years
August 26, 2008
May 21, 2010
March 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
Definitions in assessment of adverse event severity: Mild: awareness of sign, symptom, or event, but easily tolerated. Moderate: discomfort enough to cause interference with usual activity and may warrant intervention. Severe: incapacitating with inability to do usual activities or significantly affects clinical status, and warrants intervention.
The observational program was conducted over a period of 2 years
Study Arms (1)
1
Women with advanced ovarian cancer
Interventions
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
Eligibility Criteria
Women with advanced ovarian cancer with: previous platin/taxane therapy and documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
You may qualify if:
- Women with advanced ovarian cancer with:
- previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.
You may not qualify if:
- Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Steppan I, Reimer D, Sevelda U, Ulmer H, Marth C, Zeimet AG. Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity. Chemotherapy. 2009;55(6):391-8. doi: 10.1159/000262452. Epub 2009 Nov 30.
PMID: 19955744RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
February 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 15, 2015
Results First Posted
June 22, 2010
Record last verified: 2015-03