RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have advanced solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: SR-45023A	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

Study chairs or principal investigators

Susan Smith,  Study Chair,  ILEX Oncology   

Study ID Numbers:  CDR0000066975; ILEX-SR101-A9; NCI-V99-1532; ILEX-SR101; UARIZ-HSC-98161
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003822
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08