Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00743431
First received: August 26, 2008
Last updated: July 15, 2014
Last verified: July 2014

August 26, 2008
July 15, 2014
February 2005
December 2008   (final data collection date for primary outcome measure)
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) [ Time Frame: The observational program was conducted over a period of 2 years ] [ Designated as safety issue: Yes ]

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.

Safety and tolerability [ Time Frame: The observational program will be conducted over a period of 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00743431 on ClinicalTrials.gov Archive Site
Not Provided
Objective response, CA-125 response, Analysis of safety and tolerability. [ Time Frame: The observational program will be conducted over a period of 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

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.

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. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Ovarian Neoplasms
Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
1
Women with advanced ovarian cancer
Intervention: Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00743431
P04085
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

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