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Irinotecan Followed by Fluorouracil 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 Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors Clinical research trials and Irinotecan Followed by Fluorouracil 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 Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors. Irinotecan Followed by Fluorouracil 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 Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Irinotecan Followed by Fluorouracil 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 > "I" Clinical Trials Conditions > Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors  Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
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 irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.
Details: OBJECTIVES: I. Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors. II. Determine the toxic effects of this regimen in these patients. III. Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients. IV. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose de-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value - Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites) --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No prior irinotecan Endocrine therapy: Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control - No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture) Surgery: - See Disease Characteristics - At least 2 weeks since prior major surgery Other: No concurrent anticoagulants except warfarin or subcutaneous heparin --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: - WBC at least 4,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST less than 2 times ULN - Alkaline phosphatase less than 2 times ULN - Lactic dehydrogenase less than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: - HIV negative - No active uncontrolled bacterial, viral, or fungal infection - No nonmalignant systemic disease that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickCreaven, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000068895; RPCI-RP-01-01
Study Start Date: May 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024141
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
2. Phenoxodiol in Treating Patients With Refractory Solid Tumors
3. Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
4. MEN-10755 in Treating Patients With Solid Tumors
5. Buspirone in Reducing Shortness of Breath in Patients With Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors
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