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SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical research trials and SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors. SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors clinical trial. Participants typically obtain the most effective healthcare available for their SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors  SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): ILEX Oncology ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KateNolte, Study Chair, ILEX Oncology
Institute for Drug Development
San Antonio, Texas, 78245-3217
United States
Additional Information:
Study ID Numbers: CDR0000067233; ILEX-SR102-A4,NCI-V99-1560,SACI-IDD-99-06
Study Start Date: April 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004049
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
2. Creatine in Treating Patients With Cancer-Associated Weight Loss
3. BMS-184476 in Treating Patients With Advanced Solid Tumors
4. Endostatin in Treating Patients With Advanced Refractory Solid Tumors
5. Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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