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R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors Clinical research trials and R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors. R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors  R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Kaplan Cancer Center , 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors. - Determine the maximum tolerated dose of this regimen in these patients. - Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients. - Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen. - Determine activity of this treatment in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral R115777 twice daily on days 2-21 (in the first course only R115777 begins on day 3) and topotecan IV continuously on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 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 advanced solid tumor not amenable to standard curative therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 6 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 5 times ULN - No significant hepatic dysfunction that would preclude study Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular: - No significant cardiovascular dysfunction that would preclude study Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No malabsorption syndrome, partial or complete bowel obstruction, disease significantly affecting gastrointestinal function, or major resection of the stomach or proximal small bowel - At least 1 week since prior active infection requiring systemic medical therapy - No significant organ system dysfunction (neurologic, endocrine) that would preclude study - No dementia or altered mental status that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 3 prior chemotherapy regimens - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - No more than 25% of bone marrow volume irradiated - No prior pelvic radiation - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Franco Muggia 212-263-6485
Additional Information:
Study ID Numbers: CDR0000067979; NYU-9932,NCI-T99-0110
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005990
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
2. Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
3. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
4. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
5. Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
Related Studies:
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R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
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