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A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pegylated Liposomal Doxorubicin hydrochloride
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
  • Women must be greater than or equal to 18 years of age, of any race.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer.
  • Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc.
  • Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated.
  • Karnofsky performance status above 60%.
  • Left ventricular ejection fraction above 50% (according to the results of echocardiography).

  • Adequate bone marrow function as indicated by:

    • Platelets >100x10^9/L
    • Haemoglobin > 9 g/dL
    • Absolute neutrophil count >1.5x10^9/L

  • Adequate renal function as indicated by:

    • Serum creatinine < 1.5 х ULN

  • Adequate liver function as indicated by:

    • Bilirubin level and AST or ALT activity < 2 х ULN (with the exception of cases related to primary disease).

Exclusion Criteria:

  • Women who are pregnant or nursing.
  • Subjects who have not observed the designated washout periods for any of the prohibited medications.
  • Subjects who have used any investigational product within 30 days prior to enrollment.
  • Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders.
  • Non-controlled bacterial, viral or fungal infections.
  • Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients.
  • Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma).
  • Patient has symptomatic metastasis to brain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Caelyx Intravenous, 50 mg/m^2, given for 6 cycles

    Outcomes

    Primary Outcome Measures

    Number of Participants With Complete Response
    Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Number of Participants With Partial Response
    Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Number of Participants With Stabilization
    All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Number of Participants With Progression
    Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.

    Secondary Outcome Measures

    Mean Time to Positive (Partial) Treatment Response Achievement
    Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging. Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions.
    Median Time to Progression
    Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Mean Survival Time During the Study
    Mean time to the occurrence of death

    Full Information

    First Posted
    June 23, 2008
    Last Updated
    May 12, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00727961
    Brief Title
    A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
    Official Title
    Obligatory Post-Registration Open-Label, Non-Comparative Multicenter Study of Efficacy and Tolerance Rate of Caelyx as Monotherapy in Patients With Epithelial Ovarian Cancer, Resistant to Previous Platinum Therapy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 9, 2004 (Actual)
    Primary Completion Date
    January 10, 2008 (Actual)
    Study Completion Date
    January 10, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated Liposomal Doxorubicin hydrochloride
    Other Intervention Name(s)
    Caelyx
    Intervention Description
    Caelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
    Primary Outcome Measure Information:
    Title
    Number of Participants With Complete Response
    Description
    Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Time Frame
    4 weeks after chemotherapy completed
    Title
    Number of Participants With Partial Response
    Description
    Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Time Frame
    4 weeks after chemotherapy completed
    Title
    Number of Participants With Stabilization
    Description
    All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Time Frame
    4 weeks after chemotherapy completed
    Title
    Number of Participants With Progression
    Description
    Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Time Frame
    4 weeks after chemotherapy completed
    Secondary Outcome Measure Information:
    Title
    Mean Time to Positive (Partial) Treatment Response Achievement
    Description
    Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging. Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions.
    Time Frame
    from the beginning of study drug administration up to 4 weeks after chemotherapy completed
    Title
    Median Time to Progression
    Description
    Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.
    Time Frame
    from the beginning of study drug administration up to 4 weeks after chemotherapy completed
    Title
    Mean Survival Time During the Study
    Description
    Mean time to the occurrence of death
    Time Frame
    from the beginning of study drug administration up to 18 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent. Women must be greater than or equal to 18 years of age, of any race. Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer. Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc. Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated. Karnofsky performance status above 60%. Left ventricular ejection fraction above 50% (according to the results of echocardiography). Adequate bone marrow function as indicated by: Platelets >100x10^9/L Haemoglobin > 9 g/dL Absolute neutrophil count >1.5x10^9/L Adequate renal function as indicated by: Serum creatinine < 1.5 х ULN Adequate liver function as indicated by: Bilirubin level and AST or ALT activity < 2 х ULN (with the exception of cases related to primary disease). Exclusion Criteria: Women who are pregnant or nursing. Subjects who have not observed the designated washout periods for any of the prohibited medications. Subjects who have used any investigational product within 30 days prior to enrollment. Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders. Non-controlled bacterial, viral or fungal infections. Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients. Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma). Patient has symptomatic metastasis to brain.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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

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    A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)

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