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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779129
First received: October 23, 2008
Last updated: May 8, 2014
Last verified: May 2014

October 23, 2008
May 8, 2014
March 2003
September 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00779129 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)
Phase II Trial of Caelyx and Cyclophosphamide in Metastatic Breast Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasm
  • Drug: Pegylated Liposomal 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.
Experimental: Single Arm
Caelyx 35 mg/m2 and Cyclophosphamide 600 mg/m2
Interventions:
  • Drug: Pegylated Liposomal Doxorubicin
  • Drug: Cyclophosphamide
Trudeau ME, Clemons MJ, Provencher L, Panasci L, Yelle L, Rayson D, Latreille J, Vandenberg T, Goel R, Zibdawi L, Rahim Y, Pouliot JF. Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines. J Clin Oncol. 2009 Dec 10;27(35):5906-10. doi: 10.1200/JCO.2009.22.7504. Epub 2009 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2007
September 2007   (final data collection date for primary outcome measure)

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 anthracycline-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.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00779129
P02948
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Princess Margaret Hospital, Canada
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP