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LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors Clinical research trials and LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors. LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors clinical trial. Human subjects often get the best healthcare available for their LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors  LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining LY317615 with capecitabine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors. - Determine the safety profile of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the antitumor activity of this regimen in these patients. - Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral LY317615 daily on days 1-14 (course 1 only). Beginning with course 2, patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose. Patients are followed at 30 days after the last dose of study drug. PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists - Measurable or evaluable disease - No known untreated or symptomatic CNS metastases - No concurrent hematologic malignancies PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL (erythrocyte transfusions allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal - Creatinine clearance at least 50 mL/min - Potassium at least 3.4 mEq/L - Calcium at least 8.4 mg/dL - Magnesium at least 1.2 mEq/L Cardiovascular - QTc interval no greater than 450 msec in males - QTc interval no greater than 470 msec in females - No other electrocardiogram abnormalities Other - Able to swallow capsules - No gastrointestinal disorder that would interfere with oral drug absorption - No serious concurrent systemic disorder - No compliance issues that would preclude study - No geographical conditions that would preclude study - No active infection - No prior hypersensitivity to any component of study drugs - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3-6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy - No concurrent routine filgrastim (G-CSF) Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - At least 4 weeks since prior anticancer hormonal therapy - At least 6 weeks since prior bicalutamide - At least 4 weeks since prior flutamide or nilutamide - Concurrent luteinizing hormone-releasing hormone analog therapy (e.g., leuprolide or goserelin) allowed for patients with prostate cancer if started before study entry - No other concurrent hormonal therapy Radiotherapy - At least 4 weeks since prior radiotherapy - At least 2 weeks since prior palliative radiotherapy - No concurrent radiotherapy (including palliative therapy) Surgery - Not specified Other - Recovered from prior therapy - At least 4 weeks since prior investigational anticancer therapy - At least 4 weeks since other prior anticancer therapy - At least 30 days since prior experimental drugs - No other concurrent experimental medications - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynBritten, Principal Investigator, Division of Hematology/Oncology
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Carolyn Britten 310-825-8195
Additional Information:
Study ID Numbers: CDR0000258138; UCLA-0206061,LILLY-H6Q-MC-JCAH,NCI-G02-2132
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052273
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. Irinotecan in Treating Aging Patients With Solid Tumors
3. BMS-214662 in Treating Patients With Advanced Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
Related Studies:
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LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
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