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Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas 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 Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas Clinical research trials and Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas 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 Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas 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 Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas clinical trial. Participants frequently obtain the most expert healthcare available for their Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas 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 > "G" Clinical Trials Conditions > Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas  Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
For Condition: stage 4B pancreatic cancer,recurrent pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer,duct cell adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
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: Phase II trial to study the effectiveness of combining gemcitabine with ISIS 2503 in treating patients who have advanced or metastatic cancer of the pancreas.
Details: OBJECTIVES: I. Determine the 6-month and overall survival rates in patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with gemcitabine and ISIS 2503. II. Determine the response rate of these patients treated with this regimen. III. Assess the toxicity of this regimen in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and ISIS 2503 IV continuously on days 1-14. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 20-44 patients will be accrued within 10-22 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to standard curative therapy; Duct cell; Undifferentiated; The following cellular types are not eligible: Islet cell carcinoma; Acinar cell carcinoma; Cystadenocarcinoma - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy; No concurrent immunotherapy; No colony-stimulating factors during first course of therapy - Chemotherapy: No prior chemotherapy except radiosensitizing agents used in adjuvant setting or in treatment of locally advanced disease; No prior gemcitabine; No prior ISIS 2503; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to 25% or greater of bone marrow; No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; No underlying disease associated with active bleeding - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 3 times ULN; AST no greater than 3 times ULN; PT and PTT normal - Renal: Creatinine no greater than 1.5 times ULN - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, North Central Cancer Treatment Group
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000068281; NCCTG-N0043
Study Start Date: February 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006467
Other Stage 4b Pancreatic Cancer Studies:
1. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
2. Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
3. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
4. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
5. Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other North Dakota Clinical Trials
Other Fargo Clinical Trials
Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
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