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
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
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.
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
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
Learn more about this trial
A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
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