NCT00017030

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 unresectable advanced or metastatic soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 11, 2004

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 26, 2013

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

June 6, 2001

Last Update Submit

June 25, 2013

Conditions

Sarcoma

Keywords

stage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage IV adult soft tissue sarcoma

Interventions

trabectedinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic soft tissue sarcoma Unresectable disease Previously treated with at least 1 prior non-adjuvant chemotherapy regimen for advanced or metastatic disease Adjuvant chemotherapy considered first-line treatment for advanced disease if the first relapse is less than 6 months after completion of therapy At least 1 bidimensionally measurable non-irradiated lesion At least 20 mm in at least 1 diameter by CT scan At least 20 by 20 mm for clinically measurable lesion No gastrointestinal stromal sarcoma No HIV-related Kaposi's sarcoma No malignant mesothelioma No chondrosarcomas No symptomatic brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than ULN (unless suspected bone metastases present) AST/ALT less than 2.5 times ULN Albumin at least 2.5 g/dL No chronic active liver disease Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No congestive heart failure No angina pectoris, even if medically controlled No myocardial infarction within the past year No uncontrolled arterial hypertension or arrhythmias Other: No other neoplastic disease within the past 5 years except non-melanoma skin cancer or carcinoma in situ No other serious illness or medical condition No active infection No history of significant neurological or psychiatric disorders No symptomatic peripheral neuropathy grade 2 or greater Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy No concurrent prophylactic colony-stimulating factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)) during first course of study No concurrent anticancer immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: See Disease Characteristics Recovered from radiotherapy No concurrent radiotherapy except palliative local radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs No other concurrent investigational or experimental anticancer drugs No concurrent participation in other clinical trial

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

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, 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

Sarcoma

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Robert Maki, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

March 11, 2004

Study Start

February 1, 2001

Primary Completion

January 1, 2003

Study Completion

December 1, 2009

Last Updated

June 26, 2013

Record last verified: 2009-12

Locations

US(3)