Ovarian Neoplasms
Conditions
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.
Interventions
DRUGPegylated Liposomal Doxorubicin hydrochloride
Caelyx Intravenous, 50 mg/m\^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response | 4 weeks after chemotherapy completed | 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 | 4 weeks after chemotherapy completed | 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 | 4 weeks after chemotherapy completed | 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 | 4 weeks after chemotherapy completed | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Progression | from the beginning of study drug administration up to 4 weeks after chemotherapy completed | 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 | from the beginning of study drug administration up to 18 months | Mean time to the occurrence of death |
| Mean Time to Positive (Partial) Treatment Response Achievement | from the beginning of study drug administration up to 4 weeks after chemotherapy completed | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caelyx Intravenous Caelyx Intravenous, 50 mg/m\^2, given for 6 cycles | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Patient's refusal | 2 |
| Overall Study | Progression | 30 |
Baseline characteristics
| Characteristic | Caelyx Intravenous |
|---|---|
| Age, Customized | 58 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 58 |
| serious Total, serious adverse events | 8 / 58 |
Outcome results
Primary
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.
Time frame: 4 weeks after chemotherapy completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caelyx Intravenous | Number of Participants With Complete Response | 0 participants |
Primary
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.
Time frame: 4 weeks after chemotherapy completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caelyx Intravenous | Number of Participants With Partial Response | 5 Participants |
Primary
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.
Time frame: 4 weeks after chemotherapy completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caelyx Intravenous | Number of Participants With Progression | 6 Participants |
Primary
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.
Time frame: 4 weeks after chemotherapy completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caelyx Intravenous | Number of Participants With Stabilization | 10 Participants |
Secondary
Mean Survival Time During the Study
Mean time to the occurrence of death
Time frame: from the beginning of study drug administration up to 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Caelyx Intravenous | Mean Survival Time During the Study | 346.0 days |
Secondary
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.
Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caelyx Intravenous | Mean Time to Positive (Partial) Treatment Response Achievement | 128.0000 days | Standard Deviation 50.2643 |
Secondary
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.
Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Caelyx Intravenous | Median Time to Progression | 98.0 days |