Ovarian NeoplasmsPhase 4NCT00727961
A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
A Phase 4 study testing Pegylated Liposomal Doxorubicin hydrochloride in people with Ovarian Neoplasms, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Pegylated Liposomal Doxorubicin hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2004to 10 Jan 2008
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
About this study
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.
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Pegylated Liposomal Doxorubicin hydrochloride
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal Doxorubicin hydrochlorideDrug
Also called Caelyx
Caelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Caelyx Intravenous, 50 mg/m^2, given for 6 cycles Receives: Drug: Pegylated Liposomal Doxorubicin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after chemotherapy completed
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.
Measured: 4 weeks after chemotherapy completed
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.
Measured: 4 weeks after chemotherapy completed
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.
Measured: 4 weeks after chemotherapy completed
Secondary outcomes (3)
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.
Measured: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
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.
Measured: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
Mean Survival Time During the Study
Mean time to the occurrence of death
Measured: from the beginning of study drug administration up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study start9 Nov 2004
- Primary completion10 Jan 2008
- Study completion10 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727961
- Sponsor's protocol ID
- P04072
- Status last verified
- May 2017
- First submitted
- 23 Jun 2008
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00727961
- Acronym / sponsor ID
- P04072
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2004 (actual)
- Primary completion
- 10 Jan 2008 (actual)
- Study completion
- 10 Jan 2008 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Posted 16 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Pegylated Liposomal Doxorubicin hydrochlorideCaelyx Intravenous, 50 mg/m^2, given for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Liposomal Doxorubicin hydrochlorideAlso: CaelyxCaelyx Intravenous, 50 mg/m^2 (60 minute infusion) on day 1, every 4 weeks, during 6 cycles | Drug | Arm 1 |
Primary outcome
Number of Participants With Complete Response
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Mean Time to Positive (Partial) Treatment Response Achievement
Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
Median Time to Progression
Time frame: from the beginning of study drug administration up to 4 weeks after chemotherapy completed
Mean Survival Time During the Study
Time frame: from the beginning of study drug administration up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated Liposomal Doxorubicin hydrochloride in people with Ovarian 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 8 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 16 Jul 2009). 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?
Number of Participants With Complete Response (time frame: 4 weeks after chemotherapy completed). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2017.