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Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer Clinical research trials and Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer clinical trial. Participants frequently get the best healthcare available for their Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer  Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
For Condition: stage 4B pancreatic cancer,stage 4A pancreatic cancer,recurrent pancreatic cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with celecoxib in treating patients who have metastatic pancreatic cancer.
Details: OBJECTIVES: - Determine the overall survival at 6 months of patients with metastatic pancreatic cancer treated with gemcitabine and celecoxib. - Determine the objective tumor response, progression-free survival, and median survival of patients treated with this regimen. - Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive gemcitabine IV over 65 minutes on days 1, 8, and 15 and oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months from study entry and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic pancreatic cancer - Radiographic evidence of disease - No known brain metastases PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified 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 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No history of peptic ulcer disease - No gastrointestinal bleeding within the past 3 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biological composition to study drugs or to sulfonamides - No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs - No ongoing or active infection - No other uncontrolled concurrent illness - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for metastatic pancreatic cancer - More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including gemcitabine) for pancreatic cancer Endocrine therapy - Not specified Radiotherapy - See Chemotherapy - More than 6 months since prior radiotherapy Surgery - Not specified Other - More than 30 days since prior investigational agents - No other concurrent investigational or commercial agents or therapies for the malignancy - No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) - No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib) - Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325 mg/day) for cardiac prophylaxis allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryXiong, Principal Investigator, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Henry Xiong 713-792-2828
Additional Information:
Study ID Numbers: CDR0000322827; NCI-6167,MDA-2003-0288
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068432
Other Stage 4a Pancreatic Cancer Studies:
1. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
2. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
3. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
4. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
5. Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
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