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 locally advanced or metastatic solid tumors that have not responded to previous treatment.

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. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any preliminary antitumor activity of SR-45023A in these patients.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment continues every 4 weeks 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 determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 1 month.

PROJECTED ACCRUAL: A maximum of 36 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 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 symptomatic, progressive brain metastases by CT or MRI scan; No cerebral edema; No leukemia or multiple myeloma

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent immunotherapy
• Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks since carboplatin, mitomycin, or nitrosoureas) and recovered; No prior SR-45023A; No other concurrent chemotherapy
• Endocrine therapy: No concurrent steroid therapy for brain disease; No concurrent hormonal cancer therapy (except contraception, hormone replacement therapy, or corticosteroids)
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy (except symptomatic radiotherapy for pathologic fractures)
• Surgery: At least 4 weeks since prior surgery and recovered
• Other: At least 4 weeks since prior investigational agents; No other concurrent investigational agents; No concurrent anticoagulation therapy (e.g., heparin) except low dose warfarin for central venous catheter patency; No concurrent digoxin, beta blockers, or calcium channel blockers; No concurrent H2 histamine inhibitors (e.g., ranitidine, famotidine, or cimetidine), proton pump inhibitors (e.g., omeprazole or lansoprazole), or other drugs that might interfere with study drug absorption

--Patient Characteristics--

• Age: 18 and over
• Performance status: SWOG 0-2
• Life expectancy: At least 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 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); PT or INR, and PTT normal
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No cardiac conduction abnormalities
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active or uncontrolled infection; No other concurrent severe disease; No known hypersensitivity to SR-45023A analogs; No concurrent or recent (within past 6 months) small bowel obstruction, symptoms of small bowel obstruction, or any other gastrointestinal disease impacting absorption of study drug; No psychiatric disorders or geographic distance that would prevent compliance

Texas
      Institute for Drug Development, San Antonio,  Texas,  78245-3217,  United States

Study chairs or principal investigators

Kate Nolte,  Study Chair,  ILEX Oncology   

Study ID Numbers:  CDR0000067233; ILEX-SR102-A4; NCI-V99-1560; SACI-IDD-99-06
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004049
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08