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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00743431
First received: August 26, 2008
Last updated: July 15, 2014
Last verified: July 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
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: July 15, 2014
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Hand-Foot Syndrome
Ovarian Neoplasms
Adnexal Diseases
Chemically-Induced Disorders
Dermatitis
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014