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SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors Clinical research trials and SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors. SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors  SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors
SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of solid tumors by stopping blood flow to the tumor. Combining SU5416 with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 plus irinotecan and cisplatin in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of SU5416 in combination with irinotecan and cisplatin in patients with advanced solid tumors. II. Determine the quantitative and qualitative toxicity of this treatment regimen in terms of organ specificity, time course, predictability, and reversibility in this patient population. III. Determine the therapeutic response of this treatment regimen in these patients. IV. Evaluate the clinical pharmacokinetics and the relationship of kinetics to toxicity and response in this patient population treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study of SU5416. Patients receive cisplatin IV over 90 minutes immediately followed by irinotecan IV over 90 minutes and SU5416 IV over 2 hours on day 1. Patients receive SU5416 alone on day 4. Patients receive combination chemotherapy weekly for 4 weeks and SU5416 twice weekly for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 3-24 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 proven advanced solid tumor for which no curative therapy exists - No prior or concurrent primary brain tumor or brain metastasis --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy and recovered; No concurrent biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No other concurrent chemotherapy; No prior cisplatin or irinotecan - Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered; No concurrent hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow and recovered; No concurrent radiotherapy - Surgery: At least 4 weeks since prior surgery and recovered; No concurrent surgery - Other: No other concurrent investigational drugs --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; No inherited predisposition to hypercoagulation - Hepatic: Bilirubin normal; SGOT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No uncompensated coronary artery disease on electrocardiogram or physical examination; No myocardial infarction or severe unstable angina within the past 6 months; No severe peripheral vascular disease related to diabetes mellitus; No deep venous or arterial thrombosis within the past 3 months; No inherited predisposition to thrombosis - Pulmonary: No pulmonary embolism within the past 3 months - Other: No other malignancies within the past 5 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix ;No other significant medical illness; No serious active infections; Not pregnant or nursing Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricKraut, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000068008; NCI-47,OSU-00H0033
Study Start Date: October 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006000
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
2. Interleukin-12 in Treating Patients With Advanced Cancer
3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. GPX-100 in Treating Patients With Solid Tumors
5. Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
SU5416, Irinotecan, and Cisplatin in Treating Patients with Advanced Solid Tumors
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