Malignant MesotheliomaPhase 2NCT00027508
Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
A Phase 2 study testing trabectedin in people with Malignant Mesothelioma, run by PharmaMar at 4 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- trabectedin
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Jul 2001to Feb 2002
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant mesothelioma that is not amenable to curative surgery At least 1 unidimensionally measurable lesion that is at least 15 mm by CT scan OR At least 1 bidimensionally measurable lesion that is at least 10 mm by CT scan Lesions in previously irradiated area are not considered measurable unless there is evidence of progression No symptomatic brain or leptomeningeal involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than ULN unless bone metastases are present AST/ALT no greater than 2.5 times ULN Albumin at least 2.5 g/dL No chronic active liver disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No uncontrolled heart disease No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for one month after study No other serious illness or medical condition No history of significant neurological or psychiatric disorders No significant active infection No other concurrent neoplastic disease except non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic hematopoietic colony-stimulating factors (e.g., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 30 days since prior radiotherapy and recovered No concurrent radiotherapy except palliative local radiotherapy to non-target lesions Surgery: See Disease Characteristics At least 14 days since prior pleurodesis Recovered from prior surgery Other: At least 30 days since prior participation in another therapeutic clinical trial or therapy with other investigational drugs No concurrent treatment for other neoplastic disease No other concurrent experimental anticancer medication
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery.
Read the detailed description
OBJECTIVES: I. Determine partial and complete response rates in patients with unresectable malignant mesothelioma treated with ecteinascidin 743. II. Determine the toxicity profile of this drug in these patients. III. Determine the pharmacokinetic/pharmacodynamic relationships of this drug in these patients. IV. Determine the duration of response, time to disease progression, 6-month progression-free survival, time to treatment failure, and overall survival of patients treated with this drug. V. Assess the quality of life of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Quality of life is assessed at baseline and at the beginning of each course of therapy. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study within 12-24 months.
- Conditions
- Malignant Mesothelioma
- Being tested
- trabectedin
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2004 (estimated)
- Study startJul 2001
- Primary completionFeb 2002
- Study completionFeb 2002
Why it stopped: Enrolment halted prematurely and not resumed. 2 patients enrolled. No data was obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies 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
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Lee M. Krug, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027508
- Sponsor's protocol ID
- MSKCC-01084
- Other IDs
- CDR0000069034, PMAR-ET-B-020-99, NCI-G01-2026
- Status last verified
- Jun 2013
- First submitted
- 7 Dec 2001
- Last updated
- 24 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT00027508
- Acronym / sponsor ID
- MSKCC-01084
- Conditions
- Malignant Mesothelioma
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment halted prematurely and not resumed. 2 patients enrolled. No data was obtained.
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 15 Jan 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery.
Detailed description
OBJECTIVES: I. Determine partial and complete response rates in patients with unresectable malignant mesothelioma treated with ecteinascidin 743. II. Determine the toxicity profile of this drug in these patients. III. Determine the pharmacokinetic/pharmacodynamic relationships of this drug in these patients. IV. Determine the duration of response, time to disease progression, 6-month progression-free survival, time to treatment failure, and overall survival of patients treated with this drug. V. Assess the quality of life of these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Quality of life is assessed at baseline and at the beginning of each course of therapy. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study within 12-24 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| trabectedin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Enrolment halted prematurely and not resumed. 2 patients enrolled. No data was obtained.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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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.
Lee M. Krug, MD study chair
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trabectedin in people with Malignant Mesothelioma, run by PharmaMar at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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 was stopped early (reason given: Enrolment halted prematurely and not resumed. 2 patients enrolled. No data was obtained.). Results are not available in the source record.
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 24 Feb 2015.