A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally
advanced or metastatic solid tumors that are refractory or for which no standard therapy
exists. II. Determine the quantitative toxic effects of SR-45023A in these patients. III.
Assess the pharmacokinetic profile of SR-45023A in these patients. IV. Identify the
antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A twice daily for 14
days, followed by 7 days rest. On day 14 of course 1, patients receive only one dose of
therapy due to pharmacokinetic sampling. Treatment continues every 21 days in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of SR-45023A until the maximum tolerated dose (MTD) is reached. The MTD is defined as
the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients
are followed until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or
metastatic or solid tumors refractory to standard therapy or for which no standard therapy
exists (surgery, radiotherapy, and/or chemotherapy) Measurable or evaluable disease by
medical photograph, plain x-ray, CT, MRI, palpation, or serum tumor markers at least 2
times upper limit of normal No asymptomatic brain metastases No leukemia, lymphoma, or
multiple myeloma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9 g/dL No coagulation disorders Hepatic:
Bilirubin normal AST and ALT no greater than 3 times upper limit of normal (ULN) (no
greater than 5 times ULN if liver involvement) Renal: Creatinine less than 1.5 mg/dL
Creatinine clearance at least 45 mL/min Cardiovascular: No cardiac conduction
abnormalities Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception No active infection No concurrent serious systemic disorders
No concurrent or recent (within past 6 months) small bowel obstruction, symptoms of small
bowel obstruction, or any other gastrointestinal disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent
filgrastim (G-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior
chemotherapy and recovered No prior SR-45023A No other concurrent chemotherapy Endocrine
therapy: No concurrent hormonal cancer therapy (except contraception, hormone replacement
therapy, and corticosteroids) Radiotherapy: See Disease Characteristics Prior radiotherapy
allowed to less than 25% of the bone marrow and recovered No prior radiotherapy to the
whole pelvis No concurrent radiotherapy Surgery: See Disease Characteristics Other: At
least 4 weeks since prior investigational agents No other concurrent investigational
agents No concurrent anticoagulation therapy (e.g., Coumadin or heparin) No concurrent
digoxin, beta blockers, or calcium channel blockers
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Susan Smith
Investigator Role:
Study Chair
Investigator Affiliation:
Genzyme
Authority:
United States: Federal Government
Study ID:
CDR0000066975
NCT ID:
NCT00003822
Start Date:
August 1998
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
