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Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma

Phase 2
12 Years
Not Enrolling

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Trial Information

Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma

OBJECTIVES: I. Determine the partial and complete response rate in patients with previously
treated metastatic osteosarcoma when treated with ecteinascidin 743. II. Further
characterize the toxicity profile and the pharmacokinetic-pharmacodynamic relationships of
this drug in this patient population.

OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 24 hours.
Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease
progression for at least 2-6 courses. Patients with a complete response (CR) receive at
least 2 additional courses after documented CR. Patients are followed every 3 months until
disease progression. All patients are followed until death after disease progression.

PROJECTED ACCRUAL: A total of 25-33 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven osteosarcoma previously treated with
standard chemotherapy agents (methotrexate, doxorubicin/cisplatin, ifosfamide) Active
metastatic disease following chemotherapy At least 1 bidimensionally measurable lesion
located in a nonirradiated area CT scan lesion at least 20 mm in at least 1 diameter
Clinically measurable lesion at least 20 x 20 mm No symptomatic or known brain or
leptomeningeal involvement

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: WHO 0-1 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 OR Alkaline phosphatase liver fraction and 5'-nucleotidase
no greater than ULN AST/ALT less than 2.5 times ULN Albumin greater than 25 g/L No
clinically significant liver disease Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 40 mL/min Cardiovascular: No congestive heart failure or
angina pectoris even if medically controlled No myocardial infarction within past year No
uncontrolled arterial hypertension No arrhythmias Other: Not pregnant or nursing Fertile
patients must use effective contraception No history of other malignancy except basal cell
carcinoma or carcinoma in situ of the cervix No other serious illness or medical
conditions (e.g., history of significant neurological or psychiatric disorders, active
infection) No concurrent grapefruit consumption on a regular basis

PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy No
concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: See
Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other
concurrent local or systemic chemotherapy Endocrine therapy: Not specified Radiotherapy:
Recovered from prior radiotherapy No concurrent palliative or primary radiotherapy
Surgery: Not specified Other: At least 30 days since other prior investigational drugs No
other concurrent investigational drugs No concurrent participation in another clinical

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard Gorlick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

September 2003

Related Keywords:

  • Sarcoma
  • metastatic osteosarcoma
  • recurrent osteosarcoma
  • Osteosarcoma
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021