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Breast NeoplasmsPhase 4NCT00604968

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

A Phase 4 study testing Caelyx (pegylated liposomal doxorubicin; SCH 200746) in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Caelyx (pegylated liposomal doxorubicin; SCH 200746)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
7 Feb 2007to 16 Oct 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.
  • Life expectancy >= 12 weeks.
  • Patients having received oral and written information and having provided written informed consent.

Who cannot join

  • 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.
  • Myocardial infarction within 6 months of planned inclusion.
  • 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.
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  • Allergy to anthracyclines.
  • Uncontrolled infection.
  • Other not radically treated malignancy.
  • Other disease or condition contraindicating treatment or not allowing follow-up.

About this study

Official title: Caelyx(R) in Breast Cancer in the Elderly. Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer.

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.

Being tested
Caelyx (pegylated liposomal doxorubicin; SCH 200746)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT00604968
Study groupRoleWhat they receive
CaelyxExperimentalNot described
Receives: Drug: Caelyx (pegylated liposomal doxorubicin; SCH 200746)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

    Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST \& WHO were used.

    RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.

    WHO response criteria for SD required no significant change for at least 8 weeks.

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

  2. Number of Patients With Partial Response (PR) as Best Response

    Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST \& WHO were used.

    RECIST PR criteria required >=30% decrease in certain target lesions \& no increase in size of non-target lesions or appearance of new lesions

    WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks

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

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

    Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST \& WHO were used.

    RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions

    WHO PD criteria required increase in size of existing lesions or appearance of new lesions.

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

  4. Number of Patients Requiring Dose Reduction

    The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.

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

  5. Time to Response

    Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.

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

  6. Duration of Response

    Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.

    Response can be partial or complete (as previously defined), whichever status is recorded first.

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

  7. Time to Progression

    Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):

    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.

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

  8. Duration of Overall Survival

    Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.

    Measured: Time of treatment until death, up to the time that all participants ended treatment

  9. Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment

    The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study start7 Feb 2007
  3. Primary completion16 Oct 2009
  4. Study completion16 Oct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00604968
Sponsor's protocol ID
P05059
Status last verified
May 2017
First submitted
21 Jan 2008
Last updated
7 Jun 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • 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.

    PubMed 22056077

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Caelyx (pegylated liposomal doxorubicin; SCH 200746) in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604968, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.

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