Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma

June 25, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase II Study of ET-743 Given as a Three Hour Intravenous Infusion in Patients With Advanced and/or Metastatic Soft Tissue Sarcoma Previously Treated With Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the rate of clinical benefit, in terms of the incidence of objective partial and complete response, stable disease, or minor response of more than 3 months duration, in patients with previously treated, unresectable advanced or metastatic soft tissue sarcoma treated with ecteinascidin 743. II. Determine the progression-free survival, overall survival, and response duration in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the pharmacokinetic-pharmacodynamic relationship of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to number of prior cytotoxic therapies for advanced disease (1-2 vs more than 2). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36-76 patients (18-38 per stratum) will be accrued for this study within 13 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert Maki, MD, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

March 10, 2004

First Posted (Estimate)

March 11, 2004

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMAR-ET-B-022-00
  • MSKCC-01018
  • CDR0000068643 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G01-1948

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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