|
SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors conditions. Clinical Trials Search.org is a website 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 happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as 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 get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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. 3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
2. Bryostatin 1 Plus Cisplatin in Treating Patients With Metastatic or Unresectable Cancer
3. High-Dose Topotecan and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
4. Erlotinib and Irinotecan in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
|
|
|
|
|
|
|
|
