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Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer Clinical research trials and Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer. Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer  Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 2 pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Indiana University Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol followed by surgery in treating patients who have stage II or stage III pancreatic cancer.
Details: OBJECTIVES: I. Assess the biologic activity of perillyl alcohol in patients with potentially resectable, stage II or stage III pancreatic adenocarcinoma. II. Characterize the acute toxicity of this drug in these patients. III. Evaluate the antitumor activity of this drug in these patients. IV. Monitor and quantitate the plasma levels of perillyl alcohol after oral administration in this patient population. PROTOCOL OUTLINE: Patients receive oral perillyl alcohol 4 times daily on days 1-14. Patients undergo surgical resection on day 15. There is no continuation of perillyl alcohol postoperatively. Patients are followed at a minimum of 2 and 4 months following surgery. PROJECTED ACCRUAL: A total of 10 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 or cytologically confirmed stage II or stage III pancreatic adenocarcinoma that is considered resectable; Lesions should be amenable to surgery with curative intent - Bidimensionally measurable or evaluable disease - No evidence of metastatic disease - No clinically detectable third space fluid collections (e.g., ascites or effusions) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for pancreatic carcinoma - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy for pancreatic carcinoma - Surgery: See Disease Characteristics - Other: At least 1 month since prior investigational agents; At least 72 hours since prior anticoagulant therapy, cholesterol-lowering agents (e.g., lovastatin), high dosage vitamins, or antioxidants; No concurrent anticoagulants except for the sole purpose of central line patency maintenance; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.5 g/dL - Hepatic: Bilirubin no greater than 4 times upper limit of normal (ULN); PTT no greater than 1.5 times control (unless on anticoagulants) - Renal: Creatinine no greater than 1.5 times ULN - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No concurrent serious systemic disorders incompatible with study; No active infection; No second primary malignancy, previously untreated with curative intent or presently active, that would preclude curative resection of the pancreas
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickLoehrer, Study Chair, Indiana University Cancer Center
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Additional Information:
Study ID Numbers: CDR0000066895; IUMC-9710-07,NCI-T98-0046
Study Start Date: February 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003769
Other Stage 2 Pancreatic Cancer Studies:
1. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
2. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
3. Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
4. Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
5. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas
Related Studies:
Other stage 2 pancreatic cancer Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Perillyl Alcohol Followed by Surgery in Treating Patients With Stage II or Stage III Pancreatic Cancer
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