Ovarian NeoplasmsPhase 2NCT00046800
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
A Phase 2 study testing OSI-211 (Liposomal Lurtotecan) in people with Ovarian Neoplasms, run by Astellas Pharma Inc at 11 sites in 2 countries.
Trial summary
The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer. 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?
- OSI-211 (Liposomal Lurtotecan)
- How many people
- 80 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Sep 2002to Mar 2003
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed relapsed ovarian cancer.
- Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan).
- One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin.
- At least three weeks since prior chemotherapy and recovery from any related toxicities.
- At least four weeks since prior radiotherapy and recovery from any related toxicities.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom9 sites
St Chad's Unit
Birmingham, B18 7QH
Beatson Oncology Centre
Glasgow, G11 6NT
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Royal Marsden NHS Trust
London, SW3 6JJ
Northern Centre for Cancer Research, Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE
Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN
CRC Department of Medical Oncology
Sutton Surrey, SM2 5PT
Taunton & Somerset Hospital
Taunton, TA1 5DA
Medical Oncology Unit, Torbay District General Hospital
Torquay, TQ2 7AA
United States2 sites
The Sarah Cannon Cancer Center, Centennial Medical Center
Nashville, Tennessee, 37203
NYU- Kaplan Comprehensive Cancer Center
New York, New York, 10016
About this study
Official title: A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.
- Conditions
- Ovarian Neoplasms
- Being tested
- OSI-211 (Liposomal Lurtotecan)
- Keywords
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-211 (Liposomal Lurtotecan)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2002 (estimated)
- Study startSep 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- 80 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046800
- Sponsor's protocol ID
- 110-20
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2002
- Last updated
- 20 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00046800
- Acronym / sponsor ID
- 110-20
- Conditions
- Ovarian Neoplasms
- Keywords
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- OSI Pharmaceuticals
- Study start
- Sep 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 4 Oct 2002 (estimated)
- 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 this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed relapsed ovarian cancer.
- Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan).
- One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin.
- At least three weeks since prior chemotherapy and recovery from any related toxicities.
- At least four weeks since prior radiotherapy and recovery from any related toxicities.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OSI-211 (Liposomal Lurtotecan) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSI-211 (Liposomal Lurtotecan) in people with Ovarian Neoplasms, run by Astellas Pharma Inc at 11 sites in 2 countries.
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 5 inclusion and 0 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 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 20 Oct 2011.