Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
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ClinicalTrials.gov Identifier: NCT00017030 |
Recruitment Status
:
Completed
First Posted
: March 11, 2004
Last Update Posted
: June 26, 2013
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Tracking Information | ||||
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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. |
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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. |
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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. |
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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 |
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Sex/Gender |
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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 |
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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 |
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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 |