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SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer 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 SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer Clinical research trials and SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer 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 SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer 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 SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer 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 > "S" Clinical Trials Conditions > SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer  SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
For Condition: localized resectable adult primary liver cancer,adult primary hepatocellular carcinoma,adult primary cholangiocellular carcinoma,recurrent adult primary liver cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
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: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without gemcitabine followed by surgery with that of surgery alone in treating patients who have primary liver cancer.
Details: OBJECTIVES: I. Determine the biologic activity and toxicity of neoadjuvant SCH 66336 with or without gemcitabine followed by surgical resection vs surgical resection alone in patients with resectable primary liver cancer. PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to one of three treatment arms. Arm I: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days followed by surgical resection. Arm II: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days and gemcitabine IV over 30 minutes once weekly for 2 weeks followed by surgical resection. Arm III: Patients undergo surgical resection. Patients receive no neoadjuvant therapy prior to resection. PROJECTED ACCRUAL: Approximately 30 patients (10 per treatment arm) 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 or cytologically confirmed resectable primary hepatocellular carcinoma or cholangiocarcinoma - No metastatic disease to the liver --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy including estrogen therapy; No concurrent oral contraceptives or other hormonal methods; Concurrent megestrol acetate allowed; No concurrent corticosteroids (except for nausea/vomiting during gemcitabine administration) - Radiotherapy: At least 6 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 6 weeks since prior surgery and recovered - Other: At least 6 weeks since prior systemic therapy and recovered; No concurrent CYP3A4 inhibitors or inducers including: Azoles (e.g., itraconazole, clotrimazole, fluconazole, or ketoconazole); Macrolide antibiotics (e.g., azithromycin, clarithromycin, or erythromycin); Cyclosporine; Grapefruit; Antiepileptic medication (e.g., phenytoin, carbamazepine, or phenobarbital); Antibiotics for tuberculosis (e.g., rifampin or isoniazid); No concurrent HIV protease inhibitors (e.g., amprenavir, ritonavir, or saquinavir mesylate); No concurrent cisapride; No other concurrent investigational therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); SGOT or SGPT no greater than 5 times ULN; Albumin at least 2.5 g/dL; INR less than 1.3 - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: QTc prolongation no greater than 440 msec - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; No malabsorption or other gastrointestinal (GI) condition that would preclude ability to take oral medication and/or GI absorption (e.g., partial small bowel obstruction); No non-malignant systemic disease that would preclude study; No active uncontrolled infection; No grade II nausea or grade I vomiting despite antiemetic medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RafaelAmado, Study Chair, Jonsson Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000068712; NCI-G01-1958,UCLA-0002038
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020774
Other Adult Primary Hepatocellular Carcinoma Studies:
1. Vaccine Therapy in Treating Patients With Liver Cancer
2. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
3. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
4. Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma Cancer
5. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
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SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
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