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

Ovarian Neoplasms Clinical Trial

Official title:

Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743431
• Other study ID #: P04085
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: March 26, 2015
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hand-Foot Syndrome
• Ovarian Neoplasms

Intervention

Drug:
• Caelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes