Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (Study P04085) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00743431

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: Pegylated Lyposomal Doxorubicin

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and PPE.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: The observational program will be conducted over a period of 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	224
Study Start Date:	February 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Women with advanced ovarian cancer	Drug: 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. 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/taxan therapy and documented measurable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum CA 125 according to Rustin et al.

Criteria

Inclusion Criteria:

Women with advanced ovarian cancer with:
- previous platin/taxan therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum CA 125 according to Rustin et al.

Exclusion Criteria:

Patients that are not treated according to the Austrian SPC

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04085
Study First Received:	August 26, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00743431
Health Authority:	Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Doxorubicin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009