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R115777 in Treating Patients With Advanced Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about R115777 in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. R115777 in Treating Patients With Advanced Solid Tumors Clinical research trials and R115777 in Treating Patients With Advanced Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as R115777 in Treating Patients With Advanced Solid Tumors. R115777 in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a R115777 in Treating Patients With Advanced Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their R115777 in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > R115777 in Treating Patients With Advanced Solid Tumors  R115777 in Treating Patients With Advanced Solid Tumors
R115777 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Beckman Research Institute , National Cancer Institute (NCI)
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 R115777 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors. - Assess the toxicity of this drug in these patients. - Determine, preliminarily, the efficacy of this drug in these patients. - Determine the potential predictors of response in patients treated with drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy - Advanced, recurrent, or metastatic disease - Previously treated with at least 1 chemotherapy regimen - Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm3 - Absolute granulocyte count at least 1,500/mm3 - Platelet count at least 75,000/mm3 Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN Renal: - Creatinine clearance at least 60 mL/min OR - Creatinine no greater than 1.6 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic therapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) Endocrine therapy: - See Disease Characteristics - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present - No concurrent radiotherapy to measurable lesions Surgery: - See Disease Characteristics - At least 3 weeks since prior major surgery and recovered Other: - At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole) - Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrimoLara, Study Chair, University of California Davis Cancer Center
University of California Davis Cancer Center
Sacramento, California, 95817
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
City of Hope Medical Group
Pasadena, California, 91105
United States
Additional Information:
Study ID Numbers: CDR0000068963; CHNMC-PHI-33,NCI-4751
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025454
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
2. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
3. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
4. Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
5. Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
Related Studies:
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R115777 in Treating Patients With Advanced Solid Tumors
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