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Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

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Trial Information

Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma

OBJECTIVES: I. Determine partial and complete response rates in patients with unresectable
malignant mesothelioma treated with ecteinascidin 743. II. Determine the toxicity profile of
this drug in these patients. III. Determine the pharmacokinetic/pharmacodynamic
relationships of this drug in these patients. IV. Determine the duration of response, time
to disease progression, 6-month progression-free survival, time to treatment failure, and
overall survival of patients treated with this drug. V. Assess the quality of life of these
patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 3 hours on
day 1. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with a complete response (CR) receive 2
additional courses after achieving CR. Quality of life is assessed at baseline and at the
beginning of each course of therapy. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study within 12-24

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant mesothelioma
that is not amenable to curative surgery At least 1 unidimensionally measurable lesion
that is at least 15 mm by CT scan OR At least 1 bidimensionally measurable lesion that is
at least 10 mm by CT scan Lesions in previously irradiated area are not considered
measurable unless there is evidence of progression No symptomatic brain or leptomeningeal

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky
70-100% Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic:
Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than
ULN unless bone metastases are present AST/ALT no greater than 2.5 times ULN Albumin at
least 2.5 g/dL No chronic active liver disease Renal: Creatinine no greater than 1.5 mg/dL
OR Creatinine clearance at least 40 mL/min Cardiovascular: No uncontrolled heart disease
No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception during and for one month after study No
other serious illness or medical condition No history of significant neurological or
psychiatric disorders No significant active infection No other concurrent neoplastic
disease except non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic hematopoietic
colony-stimulating factors (e.g., filgrastim (G-CSF) or sargramostim (GM-CSF))
Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine
therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least
30 days since prior radiotherapy and recovered No concurrent radiotherapy except
palliative local radiotherapy to non-target lesions Surgery: See Disease Characteristics
At least 14 days since prior pleurodesis Recovered from prior surgery Other: At least 30
days since prior participation in another therapeutic clinical trial or therapy with other
investigational drugs No concurrent treatment for other neoplastic disease No other
concurrent experimental anticancer medication

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee M. Krug, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

February 2002

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma



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
Brigham and Women's Hospital Boston, Massachusetts  02115