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Gefitinib, Capecitabine, and Celecoxib 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 Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors Clinical research trials and Gefitinib, Capecitabine, and Celecoxib 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 Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors. Gefitinib, Capecitabine, and Celecoxib 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 Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors clinical trial. Subjects frequently get the best healthcare possible for their Gefitinib, Capecitabine, and Celecoxib 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 > "G" Clinical Trials Conditions > Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors  Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Colorado Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of solid tumors. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib, capecitabine, and celecoxib may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining gefitinib, capecitabine, and celecoxib in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of gefitinib and capecitabine when combined with celecoxib in patients with advanced solid tumors. - Determine the dose-limiting toxic effects of this regimen in these patients. - Determine the pharmacologic profile of this regimen in these patients. OUTLINE: This is a dose-escalation study of gefitinib and capecitabine. Patients receive oral gefitinib once daily on days 1-14, oral celecoxib twice daily on days 1-28, and oral capecitabine twice daily on days 8-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 11-41 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists - No uncontrolled brain metastases, including symptomatic lesions or lesions requiring treatment (e.g., glucocorticoids and/or anticonvulsants) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal (5 times ULN if liver metastases present) Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No active infections - No other serious concurrent systemic disorders that would preclude study participation - No other malignancy - No prior hypersensitivity to sulfonamide-based drugs, nonsteroidal anti-inflammatory drugs, or fluorouracil - No documented dihydropyrimidine dehydrogenase deficiency - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - See Disease Characteristics - No concurrent hormonal therapy Radiotherapy: - At least 28 days since prior radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - At least 4 weeks since prior investigational agents - No other concurrent experimental medications - No concurrent drugs known to induce cytochrome P450 3A4 (e.g., rifampin, phenytoin, carbamazepine, or barbiturates)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MicheleBasche, Study Chair, University of Colorado Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Michele Basche 720-848-0300
Additional Information:
Study ID Numbers: CDR0000069379; NCI-3858,UCHSC-01479
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039390
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. E7070 in Treating Patients With Solid Tumors
2. Anhydrovinblastine in Treating Patients With Advanced Recurrent Solid Tumors
3. Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
4. Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
5. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Colorado Clinical Trials
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Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
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