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LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function Clinical research trials and LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function. LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function clinical trial. Human subjects often obtain the finest healthcare possible for their LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function  LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): San Antonio Cancer Institute ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function. PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.
Details: OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose (MTD) of LY231514 in patients with metastatic or locally advanced solid tumors and varying degrees of renal function. II. Determine the recommended dose for LY231514 in this patient population. III. Examine the effects of renal dysfunction on the pharmacokinetics of LY231514 in this patient population. IV. Examine the relationship between impaired renal function, drug exposure, and drug effects in these patients. V. Gather data for development of a LY231514 dosing nomogram based on renal function. VI. Collect preliminary data regarding antitumor effects of LY231514 in this patient population. PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients are stratified according to renal function. Group 1 consists of patients with normal renal function, and groups 2, 3, and 4 consist of patients with mild, moderate, and severe renal impairment. All patients receive LY231514 IV over 10 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of LY231514 within each treatment group. If dose limiting toxicity (DLT) is observed in 1 of 3 patients at a given dose level, then 3 additional patients are studied. The maximum tolerated dose is defined as the dose level at which less than 2 of 6 patients experience DLT. Patients are followed until death. PROJECTED ACCRUAL: Up to 50 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 metastatic or locally advanced solid tumors that have failed standard therapy or for which no standard therapy exists - Measurable or evaluable disease - No active, symptomatic brain metastases - No leukemia, lymphoma, or multiple myeloma - No significant pleural or peritoneal effusions --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy; No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy (except contraceptives and corticosteroids) - Radiotherapy: At least 4 weeks since prior radiotherapy (including wide field pelvic radiation); No concurrent radiotherapy - Surgery: Not specified - Other: At least 4 weeks since prior investigational agents; Concurrent warfarin and heparin allowed; No aspirin and other nonsteroidal antiinflammatory 2 days before, the day of, and 2 days after LY231514 administration (5 days for long-acting agents); No concurrent nonsteroidal antiinflammatory drugs or salicylates with a long half-life e.g., naproxen, piroxicam, diflunisal, or nabumetone); No other concurrent experimental medications; No concurrent dialysis --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 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 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if due to liver disease); Albumin at least 2.0 g/dL - Renal: Not specified - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No active infection or serious concurrent systemic disorders; No second primary malignancy in the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin; No body surface area greater than 3 m2
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricRowinsky, Study Chair, San Antonio Cancer Institute
San Antonio Cancer Institute
San Antonio, Texas, 78229-3264
United States
Additional Information:
Study ID Numbers: CDR0000066814; UTHSC-9785011141,NCI-V98-1500,LILLY-H3E-MC-JMAW(a),SACI-IDD-97-29
Study Start Date: April 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003706
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
2. Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
3. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
4. Bupropion and Counseling With or Without Contigency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
5. UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
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LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
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