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SR-45023A in Treating Patients With Advanced Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on SR-45023A in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. SR-45023A in Treating Patients With Advanced Solid Tumors Clinical research trials and SR-45023A in Treating Patients With Advanced Solid Tumors healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including SR-45023A in Treating Patients With Advanced Solid Tumors. SR-45023A in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a SR-45023A in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their SR-45023A in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SR-45023A in Treating Patients With Advanced Solid Tumors  SR-45023A in Treating Patients With Advanced Solid Tumors
SR-45023A in Treating Patients With Advanced 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 advanced solid tumors.
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.
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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanSmith, Study Chair, ILEX Oncology
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: CDR0000066975; ILEX-SR101-A9,NCI-V99-1532,ILEX-SR101,UARIZ-HSC-98161
Study Start Date: August 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003822
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Chemotherapy in Treating Patients With Solid Tumors
2. VX-853 in Treating Patients With Solid Tumors Who Are Receiving Liposomal Doxorubicin
3. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
4. S-3304 in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Arizona Clinical Trials
Other Tucson Clinical Trials
SR-45023A in Treating Patients With Advanced Solid Tumors
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