Brief Title
Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
Official Title
Phase II Study Of ET-743 In Patients With Unresectable Malignant Pleural Mesothelioma
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 malignant mesothelioma that cannot be removed by surgery.
Detailed Description
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
months.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
trabectedin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
July 2001
Completion Date
February 2002
Primary Completion Date
February 2002
Eligibility 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 involvement
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lee M. Krug, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00027508
Organization ID
MSKCC-01084
Secondary IDs
CDR0000069034
Study Sponsor
PharmaMar
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Lee M. Krug, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013