Endometrial NeoplasmsPhase 2NCT00050440
Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma
A Phase 2 study testing Trabectedin and Dexamethasone in people with Endometrial Neoplasms and Uterine Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 14 sites in 4 countries.
Trial summary
The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female Urogenital Neoplasms
- What is being tested?
- Trabectedin and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Jul 2002to Jul 2004
- 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
- Diagnosis of advanced or metastatic endometrial carcinoma
- Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Performance status ECOG 0 or 1
Who cannot join
- Prior exposure to trabectedin
- Known hypersensitivity to dexamethasone or to any of the components of trabectedin
- Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
- History of another neoplastic disease unless in remission for more than 5 years
- Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
- Current pregnancy, lactation, or childbearing potential without adequate method of contraception.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States8 sites
Study site
Baltimore, Maryland
Study site
Dallas, Texas
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Russia4 sites
Study site
Moscow
Study site
Obninsk
Study site
Saint
Study site
Saint Petersburg
About this study
Official title: A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
Read the detailed description
Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.
- Being tested
- Trabectedin, Dexamethasone
- Keywords
- Endometrial, Cancer, Carcinoma, Trabectedin, Ecteinascidin 743, ET743, Antineoplastic Agents, Alkylating Agents, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
Trabectedin 1.3 mg/m2 administered intravenously every 21 days.
DexamethasoneDrug
Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin | Experimental | Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose. Receives: Drug: Trabectedin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with objective response
Measured: Up to approximately 3 years
Secondary outcomes (4)
Overall survival (OS)
Measured: Up to approximately 3 years
The number of patients with adverse events
Measured: Up to approximately 3 years
Time to progression (TTP)
Measured: Up to approximately 3 years
Progression free survival (PFS),
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJul 2002
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00050440
- Sponsor's protocol ID
- CR004429
- Other IDs
- ET743-USA-1
- Status last verified
- Jan 2013
- First submitted
- 9 Dec 2002
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00050440
- Acronym / sponsor ID
- CR004429
- Keywords
- Endometrial, Cancer, Carcinoma, Trabectedin, Ecteinascidin 743, ET743, Antineoplastic Agents, Alkylating Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PharmaMar
- Study start
- Jul 2002
- Study completion
- Jul 2004 (actual)
- First posted
- 10 Dec 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 is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
Detailed description
Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabectedin | Experimental | Drug: Trabectedin, Drug: DexamethasoneTrabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose. |
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)
- Diagnosis of advanced or metastatic endometrial carcinoma
- Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
- At least one measureable tumor lesion
- Adequate bone marrow, hepatic and renal function
- Performance status ECOG 0 or 1
Key exclusion criteria (6 listed)
- Prior exposure to trabectedin
- Known hypersensitivity to dexamethasone or to any of the components of trabectedin
- Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
- History of another neoplastic disease unless in remission for more than 5 years
- Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
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 |
|---|---|---|
| TrabectedinTrabectedin 1.3 mg/m2 administered intravenously every 21 days. | Drug | Trabectedin |
| DexamethasoneDexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose | Drug | Trabectedin |
Primary outcome
Number of patients with objective response
Time frame: Up to approximately 3 years
4 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 3 years
The number of patients with adverse events
Time frame: Up to approximately 3 years
Time to progression (TTP)
Time frame: Up to approximately 3 years
Progression free survival (PFS),
Time frame: Up to approximately 3 years
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 8 Jan 2013.
- McMeekin DS, Lisyanskaya A, Crispens M, et al. Single-agent trabectedin as second-line therapy of persistent or recurrent endometrial cancer: results of a multi-center phase II study. Gynecol Oncol. 2009;114(2):288-92.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.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trabectedin and Dexamethasone in people with Endometrial Neoplasms and Uterine Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 14 sites in 4 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 6 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Russia, Canada, Netherlands. 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.
What does the primary outcome measure?
Number of patients with objective response (time frame: Up to approximately 3 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 Jan 2013.