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Ovarian NeoplasmsPhase 2NCT00050414

A Study of Trabectedin in Patients With Advanced Ovarian Cancer

A Phase 2 study testing Trabectedin and Dexamethasone in people with Ovarian Neoplasms and Endocrine Gland Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Trabectedin and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
No sites listed yet
Study dates
Oct 2002to Sep 2005
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 epithelial ovarian cancer
  • Progression or recurrence during or after platinum-containing regimen
  • At least one measureable tumor lesion
  • Adequate bone marrow, hepatic and renal function
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Who cannot join

  • Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
  • Pregnant or lactating women
  • Known metastases (spread) of cancer to the central nervous system
  • History of another neoplastic disease unless in remission for five years or more.

About this study

Official title: Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian 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. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

Being tested
Trabectedin, Dexamethasone
Keywords
Ovarian cancer, Ovary, Cancer, Trabectedin, Yondelis, ET743, Ecteinascidin 743, Antineoplastic Agents, Alkylating, Alkylating Agents
Medical subject headings
Ovarian Neoplasms, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Ovarian Diseases, Adnexal Diseases, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrabectedinDrug

    Trabectedin 0.58 mg/m2, administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression.

  • DexamethasoneDrug

    Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.

Study groups in NCT00050414
Study groupRoleWhat they receive
TrabectedinExperimentalTrabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
Receives: Drug: Trabectedin; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with objective response

    Measured: Up to approximately 3 years

Secondary outcomes (8)

  1. The number of patients with an unbiased objective response

    Measured: Up to approximately 3 years

  2. Progression-free survival

    Measured: Up to approximately 3 years

  3. Time to progression

    Measured: Up to approximately 3 years

  4. Overall survival

    Measured: Up to approximately 3 years

  5. Duration of response

    Measured: Up to approximately 3 years

  6. Duration of stable disease

    Measured: Up to approximately 3 years

  7. Cancer antigen 125 (CA125) response

    Measured: Up to approximately 3 years

  8. The number of patients with adverse events

    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.

  1. First posted10 Dec 2002 (estimated)
  2. Study startOct 2002
  3. Study completionSep 2005

Resources

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
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00050414
Sponsor's protocol ID
CR004057
Other IDs
ET743-INT-11
Status last verified
Jan 2013
First submitted
9 Dec 2002
Last updated
10 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trabectedin and Dexamethasone in people with Ovarian Neoplasms and Endocrine Gland Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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 4 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 10 Jan 2013. 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 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?

On the ClinicalTrials.gov record for NCT00050414.

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 10 Jan 2013.

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