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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:
Merck
ClinicalTrials.gov Identifier:
NCT00743431
First received: August 26, 2008
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Ovarian Neoplasms
 Drug: Caelyx (Pegylated Lyposomal Doxorubicin)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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.



Enrollment: 224
Study Start Date: February 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Women with advanced ovarian cancer
 Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00743431     History of Changes
Other Study ID Numbers: P04085
Study First Received: August 26, 2008
Results First Received: May 21, 2010
Last Updated: April 18, 2013
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013