Ovarian CancerPhase 2NCT03335241
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
A Phase 2 study testing Fludarabine and Pegylated liposomal doxorubicin and Pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Fludarabine and Pegylated liposomal doxorubicin and Pegylated liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
- Platinum resistant or refractory ovarian cancer
- At least treated with one line of platinum-based chemotherapy
- Female, age ≥18 years and ≤70 years, signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
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- Patients must have a life expectancy of at least 3 months.
- Patients must have adequate organ function as defined by the following criteria:
- White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10^9/L
- Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN
- Serum creatinine ≤ 1 x ULN
- Symptomatic central nervous system (CNS) metastasis
Who cannot join
- Has known allergies to any of the excipients.
- Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
- LVEF (left ventricular ejection fraction) <50%
- Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy
- History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
- Known significant chronic liver disease, such as cirrhosis or active hepatitis
- Uncontrollable active infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer
Guangzhou, Guangdong, 510060
Jundong Li, +86-20-87343104, lijd@sysucc.org.cn
Yin Wang, +86-20-87343104, wangyin@sysucc.org.cn
About this study
Official title: An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
Read the detailed description
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. Approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence. The overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. The 5-year overall survival rates are less than 20%. Therefore, it is important to seek alternative agent that can improve the outcome. Fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through DNA synthesis interference and apoptosis. The preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Fludarabine and Pegylated liposomal doxorubicin, Pegylated liposomal doxorubicin
- Keywords
- Ovarian Cancer, Fludarabine, Pegylated Liposomal Doxorubicin, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine and Pegylated liposomal doxorubicinDrug
Fludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle
Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks
Pegylated liposomal doxorubicinDrug
Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Fludarabine and Pegylated liposomal doxorubicin | Experimental | Not described Receives: Drug: Fludarabine and Pegylated liposomal doxorubicin |
| Arm 2: Pegylated liposomal doxorubicin | Active comparator | Not described Receives: Drug: Pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD
Measured: Up to four years
Secondary outcomes (1)
Objective response rate
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Measured: Up to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Mar 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jundong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335241
- Sponsor's protocol ID
- 308-2016-03-01
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised Phase II Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03335241
- Acronym / sponsor ID
- 308-2016-03-01
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Fludarabine, Pegylated Liposomal Doxorubicin, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
Detailed description
Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. Approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence. The overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. The 5-year overall survival rates are less than 20%. Therefore, it is important to seek alternative agent that can improve the outcome. Fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through DNA synthesis interference and apoptosis. The preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Fludarabine and Pegylated liposomal doxorubicin | Experimental | Drug: Fludarabine and Pegylated liposomal doxorubicin |
| Arm 2: Pegylated liposomal doxorubicin | Active comparator | Drug: Pegylated liposomal doxorubicin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
- Platinum resistant or refractory ovarian cancer
- At least treated with one line of platinum-based chemotherapy
- Female, age ≥18 years and ≤70 years, signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (7 listed)
- Has known allergies to any of the excipients.
- Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
- LVEF (left ventricular ejection fraction) <50%
- Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy
- History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
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 |
|---|---|---|
| Fludarabine and Pegylated liposomal doxorubicinFludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks | Drug | Arm 1: Fludarabine and Pegylated liposomal doxorubicin |
| Pegylated liposomal doxorubicinPegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks | Drug | Arm 2: Pegylated liposomal doxorubicin |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to four years
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD
1 secondary outcome
Objective response rate
Time frame: Up to four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine and Pegylated liposomal doxorubicin and Pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Sun Yat-sen University at 1 site in China.
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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jundong Li (+86-20-87343104, lijd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to four years). 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 13 Nov 2017.