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DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer Clinical research trials and DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer. DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer  DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
For Condition: stage 4A pancreatic cancer,recurrent pancreatic cancer,stage 4B pancreatic cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.
Details: OBJECTIVES: - Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel. - Determine the overall survival of patients treated with this drug. - Determine the toxicity profile of this drug in these patients. - Assess the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at completion of treatment. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21-50 patients 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 or cytologically confirmed carcinoma of the pancreas - Metastatic disease - Measurable disease - Lesions within a previously irradiated field are not considered measurable - No islet cell tumors, lymphoma, or sarcoma of the pancreas - No known or clinical evidence of CNS metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled ventricular arrhythmia - No myocardial infarction within the past 3 months - No superior vena cava syndrome Neurologic: - No peripheral neuropathy greater than grade 1 - No uncontrolled major seizure disorder - No spinal cord compression Other: - No concurrent serious infection requiring parenteral therapy - No unstable or serious concurrent medical condition - No other prior malignancy except: - Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR - Other cancer curatively treated with surgery alone that has not recurred for more than 5 years - No psychiatric disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - No prior chemotherapy for metastatic disease - Prior adjuvant chemoradiotherapy allowed - At least 28 days since prior chemotherapy and recovered - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy except megestrol Radiotherapy: - See Disease Characteristics - Prior adjuvant chemoradiotherapy allowed - At least 28 days since prior large-field radiotherapy and recovered - No concurrent radiotherapy Surgery: - At least 14 days since prior major surgery and recovered Other: - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RossDonehower, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Kliniken Essen - Mitte
ESSEN, , D-45136
Germany
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Krankenhaus Nordwest
Frankfurt, , D-60488
Germany
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
New Cross Hospital
Wolverhampton, England, WV10 0QP
United Kingdom
Erasmus Medical Center
Rotterdam, , 3008 EA
Netherlands
Additional Information:
Study ID Numbers: CDR0000068926; VMRC-8770,PROTARGA-P01-00-03,THERADEX-P01-00-03
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024375
Other Stage 4b Pancreatic Cancer Studies:
1. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
2. Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
3. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Colorectal Cancer or Pancreatic Cancer
4. Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer
5. Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other England Clinical Trials
Other Wolverhampton Clinical Trials
DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
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