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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

December 2009

Related Keywords:

  • Sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma



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