A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Schering-Plough Princess Margaret Hospital, Canada
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00779129

Purpose

Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.

Condition	Intervention	Phase
Breast Neoplasm	Drug: Pegylated Lyposomal Doxorubicin Drug: Cyclophosphamide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Myocet

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Time to response; Duration of response; Time to progression; Survival [ Time Frame: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Left ventricular ejection fraction (LVEF), (MUGA Scan); Radiological imaging; Examination of adverse events, laboratory data, vital signs [ Time Frame: LVEF following cycles 2, 4, 5, and 6 of study drug; Radiological imaging every 6 weeks. ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	March 2003
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2	Drug: Pegylated Lyposomal Doxorubicin Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. Drug: Cyclophosphamide Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Arms

Assigned Interventions

Single Arm: Experimental

Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2

Drug: Pegylated Lyposomal Doxorubicin

Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Drug: Cyclophosphamide

Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, aged >=18 years.
Subject must have histologic diagnosis of breast carcinoma.
Subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging.
Subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy.
Subject must have ECOG performance status 0, 1, or 2.
Subject must have life expectancy > 6 months
Subject must have left ventricular ejection fraction >=55% as determined by MUGA scan.
Subject must have normal organ function, except if abnormal due to tumor involvement:
- Adequate bone marrow function (platelets >=100 X 10^9/L, hemoglobin >=90 g/L, Neutrophils >=1.5 X 10^9/L)
- Adequate renal function (serum creatinine < 2 X the upper limit of normal (ULN)
- Adequate liver function (bilirubin < 2 times ULN, AST or ALT < 2 times ULN in the absence of liver metastasis, AST or ALT < 5 times ULN in the presence of liver metastasis.
Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
Subject must be able to understand and give informed consent.

Exclusion Criteria:

Age > 75 years old.
Subject who is pregnant or breastfeeding or is unwilling to use adequate contraception.
Subject who has had a previous chemotherapy for metastatic disease.
Subject who has history of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure.
Subject who has clinically significant hepatic disease in regard to Hepatitis B, Hepatitis C, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer.
Subject who has uncontrolled bacterial, viral, or fungal infection.
Subject who exhibits confusion or disorientation.
Subject with any condition which would prevent adequate follow-up.
Subject who has received radiotherapy in the last 4 weeks.
Subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
Subject who has brain metastasis.
Subject who is not able to give informed consent.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02948
Study First Received:	October 23, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779129 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Anti-Bacterial Agents
Immunologic Factors
Skin Diseases
Breast Neoplasms
Antineoplastic Agents, Alkylating
Cyclophosphamide

Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Cyclophosphamide
Antibiotics, Antineoplastic
Immunosuppressive Agents
Doxorubicin

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Breast Diseases

ClinicalTrials.gov processed this record on September 01, 2009