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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00779129
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer

Resource links provided by NLM:


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
Experimental: Single Arm
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.
Other Name: SCH 200746
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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00779129     History of Changes
Other Study ID Numbers: P02948
Study First Received: October 23, 2008
Last Updated: October 23, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on April 16, 2014