Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)

NCT00604968 | Terminated Phase 4 Results

• 1 other identifier: P05059
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).

  Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: \>=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.

  Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).

Secondary Outcomes (9)

• Number of Patients With Stable Disease (SD) as Best Response

  Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).

• Number of Patients With Partial Response (PR) as Best Response

  Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).

• Number of Patients With Progressive Disease (PD) as Best Response

  Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).

• Number of Patients Requiring Dose Reduction

  Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).

• Time to Response

  Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).

Study Arms (1)

Caelyx

EXPERIMENTAL

Drug: Caelyx (pegylated liposomal doxorubicin; SCH 200746)

Interventions

Caelyx (pegylated liposomal doxorubicin; SCH 200746) DRUG

Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg).

Caelyx

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients meeting the following criteria will be eligible for enrollment.
• Female patients with histologic or cytologic diagnosis of breast cancer that is locally advanced or metastatic, and not amenable to surgery.
• Age \>= 65 years.
• World Health Organization (WHO) Performance Status 0 - 2
• Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included.
• Left ventricular ejection fraction (LVEF) \>= 50% verified by ultrasound cardiography (UCG); no clinical signs of heart disease.
• Normal organ function, except due to disease involvement, however maximum deviation:
• S-creatinine \<= 1.5 x upper normal limit;
• Bilirubin \<= 2 x upper normal limit;
• Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \<= 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT \<= 5 x upper normal limit.
• Adequate bone marrow function, ie:
• Platelets \>= 100 x 10\^9/L;
• Neutrophils \>= 1.5 x 10\^9/L;
• White Blood Cell (WBC) \>= 3.0 x 10\^9/L;
• Hemoglobin \> 90 g/L.

You may not qualify if:

• Patients will not be enrolled if any of the following conditions apply.
• Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or single-drug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.)
• Recurrence \<= 12 months after adjuvant anthracycline-containing treatment and/or prior doxorubicin \> 300 mg/m\^2 or epirubicin \> 540 mg/m\^2.
• Symptomatic brain metastases.
• Human Epidermal growth factor Receptor 2 (HER-2) positivity eligible for treatment with trastuzumab, or estrogen receptor (ER) positivity eligible for hormonal therapy.
• Allergy to anthracyclines.
• Uncontrolled infection.
• Other not radically treated malignancy.
• Other disease or condition contraindicating treatment or not allowing follow-up.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Green H, Stal O, Bachmeier K, Backlund LM, Carlsson L, Hansen J, Lagerlund M, Norberg B, Franzen A, Aleskog A, Malmstrom A. Pegylated liposomal doxorubicin as first-line monotherapy in elderly women with locally advanced or metastatic breast cancer: novel treatment predictive factors identified. Cancer Lett. 2011 Dec 27;313(2):145-53. doi: 10.1016/j.canlet.2011.07.017. Epub 2011 Aug 31.

  PMID: 22056077 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: January 30, 2008
• Study Start: February 7, 2007
• Primary Completion: October 16, 2009
• Study Completion: October 16, 2009
• Last Updated: June 7, 2017
• Results First Posted: May 2, 2011

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share