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Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical research trials and Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors clinical trial. Subjects frequently get the best healthcare possible for their Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors  Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering 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 combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors. - Determine the clinical pharmacokinetics of this regimen, as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients. - Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients. - Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen. OUTLINE: This is a dose-escalation, open-label, non-randomized study of flavopiridol. Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. During the first week of the second course, patients receive flavopiridol alone on day 1 and irinotecan alone on day 2. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment. An additional 10 patients are treated at the MTD. PROJECTED ACCRUAL: A total of 44-50 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists - Eligible for treatment at the maximum tolerated dose only if disease accessible for tissue biopsy by Tru-Cut, CT guidance, or endoscopy - Pleural effusions or abdominal ascites do not constitute adequate tissue for biopsy - No known CNS metastasis or primary CNS tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Total 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 and SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No cardiac arrhythmias, congestive heart failure, or myocardial infarction within the past 6 months Other: - Not pregnant or nursing (during and for at least 2 months after study) - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 2 months after study - No concurrent serious or uncontrolled infection - HIV negative - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior irinotecan allowed Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics Other: - Recovered from prior therapy - No other concurrent investigational medication - No concurrent vitamins (except a single multivitamin tablet), antioxidants, or herbal preparations or supplements - No concurrent subcutaneous heparin or heparinoids
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068316; MSKCC-00091,NCI-2272
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006485
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
2. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
3. Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors
4. Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
5. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
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