|
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic 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 Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer Clinical research trials and Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic 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 Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic 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 Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic 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.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer  Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
For Condition: adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 4B pancreatic cancer,recurrent pancreatic cancer
Status: Recruiting
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of cancer cells by stopping blood flow to the tumor. Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of bevacizumab with or without docetaxel in treating patients who have metastaticpancreatic cancer.
Details: OBJECTIVES: - Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel. - Determine the objective response rate and overall survival of patients treated with these regimens. - Determine the incidence of thromboembolic events in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15. - Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Metastatic disease - Unidimensionally measurable disease outside of the pancreas - At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 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 - Hemoglobin at least 9.0 g/dL (transfusion allowed) - No bleeding diathesis or coagulopathy Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and ALT no greater than 1.5 times ULN - INR no greater than ULN - PTT no greater than ULN Renal - Creatinine no greater than 2.0 mg/dL - No clinically significant renal impairment - No 1+ or greater proteinuria OR - Protein no greater than 500 mg/24 hours Cardiovascular - No prior myocardial infarction - No prior stroke - No clinically significant cardiovascular disease - No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication) - No unstable angina - No New York Heart Association class II-IV congestive heart failure - No serious cardiac dysrhythmia requiring medication - No peripheral vascular disease - No concurrent thromboembolic disease requiring anticoagulation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy) - No other medical condition that would preclude study participation - No psychiatric condition that would preclude study participation - No other prior or concurrent malignancy that would preclude study participation - No significant traumatic injury within the past 28 days - No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic granulocyte or platelet growth factors Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - More than 7 days since prior fine needle aspirations or core biopsies - More than 28 days since prior surgery (except closed biopsy or access port placement) - More than 28 days since prior open biopsy - No concurrent surgery Other - More than 4 weeks since prior experimental drug study participation - More than 4 weeks since prior investigational drugs - No other concurrent experimental drug study participation - No concurrent chronic daily aspirin (greater than 325 mg/day) - No concurrent chronic daily nonsteroidal anti-inflammatory medications - No concurrent warfarin or heparin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenCohen, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Steven Cohen 215-728-2450
Additional Information:
Study ID Numbers: CDR0000316454; FCCC-03003
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066677
Other Stage 4a Pancreatic Cancer Studies:
1. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
2. Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer
3. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
4. Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
5. Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
|
|
|
|
|
|
|
|
