NCT00027508

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 15, 2004

Completed
Last Updated

February 24, 2015

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

December 7, 2001

Last Update Submit

February 23, 2015

Conditions

Malignant Mesothelioma

Keywords

advanced malignant mesotheliomarecurrent malignant mesothelioma

Interventions

trabectedinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lee M. Krug, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 15, 2004

Study Start

July 1, 2001

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

February 24, 2015

Record last verified: 2013-06

Locations

US(4)