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

Tracking Information
First Submitted Date ICMJE	June 6, 2001
First Posted Date ICMJE	March 11, 2004
Last Update Posted Date	June 26, 2013
Study Start Date ICMJE	February 2001
Actual Primary Completion Date	January 2003 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00017030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
Official Title ICMJE	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
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.
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 ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Sarcoma
Intervention ICMJE	Drug: trabectedin
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	December 2009
Actual Primary Completion Date	January 2003 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00017030
Other Study ID Numbers ICMJE	PMAR-ET-B-022-00; MSKCC-01018; CDR0000068643 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-G01-1948
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Memorial Sloan Kettering Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Robert Maki, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account	National Cancer Institute (NCI)
Verification Date	December 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP