PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
PHASE I CLINICAL AND PHARMACOKINETIC STUDY TO DETERMINE THE SAFETY OF ECTEINASCIDIN-743 (ET-743) ADMINISTERED AS A SINGLE INTRAVENOUS INFUSION OVER 60 MINUTES EVERY 21 DAYS IN PATIENTS WITH SOLID TUMORS
OBJECTIVES: I. Estimate the maximum tolerated dose (MTD) of ecteinascidin-743 (ET-743) when
administered as a single intravenous infusion every 21 days in adults with solid tumors not
amenable to standard therapy. II. Describe the qualitative and quantitative toxic effects of
ET-743, and study the predictability, duration, intensity, onset, reversibility, and
dose-relationship of these toxic effects in these patients. III. Propose a safe dose for a
phase II study based on the MTD determined on this study. IV. Assess the pharmacokinetics of
ET-743 at different dose levels. V. Document any antitumor effects of ET-743 in these
patients.
OUTLINE: This is a multicenter study. All patients receive ET-743 IV over 3 hours every 21
days for 4 courses. Treatment continues in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ET-743 until the
maximum tolerated dose is determined. Patients are followed at 1 month, then every 3 months
until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not
amenable to standard therapy No evidence of brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases normal
(no greater than 2.5 times normal if liver metastases) Alkaline phosphatase normal (no
greater than 2.5 times normal if liver or bone metastases) No history of chronic liver
disease, e.g., chronic active hepatitis, cirrhosis Renal: Creatinine no greater than 1.4
mg/dL Creatinine clearance at least 60 mL/min Other: No active bacterial infection (e.g.,
abscess) or with fistulae No grade 2 or worse neurotoxicity No concurrent medical
condition that precludes treatment No history of alcoholism, drug addiction, or psychotic
disorder Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Colony-stimulating factors allowed for
specific indications At least 4 weeks since prior biologic therapy, immunotherapy, or
growth factors Chemotherapy: No prior intensive chemotherapy with bone marrow or stem cell
support At least 4 weeks since chemotherapy (6 weeks since nitrosoureas, mitomycin, or
high-dose carboplatin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since radiotherapy Concomitant palliative local radiotherapy allowed for existing lesion
Surgery: Recovered from prior surgery Other: No concurrent investigational drug Concurrent
prophylactic antiemetics allowed after first therapy course
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Chris Twelves, MD, BMedSci, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
University of Glasgow
Authority:
United States: Federal Government
Study ID:
EORTC-16951
NCT ID:
NCT00002904
Start Date:
February 1996
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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