LiposarcomaPhase 2NCT00060944
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
A Phase 2 study testing Yondelis and Dexamethasone in people with Liposarcoma and Leiomyosarcoma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 39 sites in 8 countries.
Trial summary
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liposarcoma, Leiomyosarcoma
- What is being tested?
- Yondelis and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 39 sitesin 8 countries
- Study dates
- May 2003to May 2008
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
- Have a pathology specimen available for centralized review
- Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
- Have adequate bone marrow, liver and kidney function
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
- Cancer that has metastasized (spread) to the central nervous system
- Active viral hepatitis or chronic liver disease
- Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
- History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
United States20 sites
Study site
Ann Arbor, Michigan
Study site
Aurora, Colorado
Study site
Boston, Massachusetts
Study site
Cleveland, Ohio
Study site
Coeur d'Alene, Idaho
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Park Ridge, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, Minnesota
Study site
Salt Lake City, Utah
Study site
Seattle, Washington
Canada5 sites
Study site
Calgary, Alberta
Study site
Edmonton
Study site
London, Ontario
Study site
Ottawa, Ontario
Study site
Toronto, Ontario
Australia4 sites
Study site
East Melbourne
Study site
Newcastle
Study site
Perth
Study site
Woodville
Russia4 sites
Study site
Moscow
Study site
Obninsk
Study site
Saint Petersburg
Study site
Samara
About this study
Official title: A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Read the detailed description
This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.
- Conditions
- Liposarcoma, Leiomyosarcoma
- Being tested
- Yondelis, Dexamethasone
- Keywords
- Trabectedin, Yondelis, ET-743, Ecteinascidin, Anthracycline, Ifosfamide, Dexamethasone, Intravenous, Cancer, Malignant, Metastatic
- Medical subject headings
- Liposarcoma, Leiomyosarcoma, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YondelisDrug
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
YondelisDrug
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
DexamethasoneDrug
Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
DexamethasoneDrug
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
| Study group | Role | What they receive |
|---|---|---|
| Yondelis weekly schedule | Experimental | Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. Receives: Drug: Yondelis; Drug: Dexamethasone |
| Yondelis once every 3 weeks schedule | Experimental | Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion. Receives: Drug: Yondelis; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression- Independent Review
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
Measured: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Secondary outcomes (4)
Percentage of Participants Objective Response - Independent Review
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Measured: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Duration of Response - Independent Review
Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
Measured: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Progression-Free Survival - Independent Review
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Measured: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Overall Survival
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
Measured: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2003 (estimated)
- Study startMay 2003
- Primary completionMay 2008
- Study completionMay 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 LiposarcomaStudies 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
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060944
- Sponsor's protocol ID
- CR004336
- Other IDs
- ET743-STS-201
- Status last verified
- Aug 2014
- First submitted
- 16 May 2003
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
- ClinicalTrials.gov ID
- NCT00060944
- Acronym / sponsor ID
- CR004336
- Conditions
- Liposarcoma, Leiomyosarcoma
- Keywords
- Trabectedin, Yondelis, ET-743, Ecteinascidin, Anthracycline, Ifosfamide, Dexamethasone, Intravenous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Study start
- May 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 May 2003 (estimated)
- Results
- Posted 8 Sep 2014
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 test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.
Detailed description
This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yondelis weekly schedule | Experimental | Drug: Yondelis, Drug: DexamethasoneYondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. |
| Yondelis once every 3 weeks schedule | Experimental | Drug: Yondelis, Drug: DexamethasoneYondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
- Have a pathology specimen available for centralized review
- Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
- Have adequate bone marrow, liver and kidney function
- Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (5 listed)
- Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
- Cancer that has metastasized (spread) to the central nervous system
- Active viral hepatitis or chronic liver disease
- Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
- History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment
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 |
|---|---|---|
| Yondelis1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. | Drug | Yondelis once every 3 weeks schedule |
| Yondelis0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. | Drug | Yondelis weekly schedule |
| DexamethasonePretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. | Drug | Yondelis weekly schedule |
| DexamethasonePretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion. | Drug | Yondelis once every 3 weeks schedule |
Primary outcome
Time to Progression- Independent Review
Time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
4 secondary outcomes
Percentage of Participants Objective Response - Independent Review
Time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Duration of Response - Independent Review
Time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Progression-Free Survival - Independent Review
Time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Overall Survival
Time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Demetri GD et al. J Clin Oncol. 2009;27(25):4188-96.Link provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yondelis and Dexamethasone in people with Liposarcoma and Leiomyosarcoma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 39 sites in 8 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 5 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, Australia, Russia, France and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2014). 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?
Time to Progression- Independent Review (time frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 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 8 Sep 2014.