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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006467 |
Purpose
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.
| Condition | Intervention | Phase |
|
Pancreatic Cancer |
Drug: ISIS 2503 Drug: gemcitabine hydrochloride |
Phase II |
| MedlinePlus related topics: | Cancer Pancreatic Cancer |
| Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma |
| Study Start Date: | February 2001 |
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.
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
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
Contacts and Locations| United States, Arizona | |||||
| CCOP - Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Illinois | |||||
| CCOP - Carle Cancer Center | |||||
| Urbana, Illinois, United States, 61801 | |||||
| United States, Iowa | |||||
| CCOP - Cedar Rapids Oncology Project | |||||
| Cedar Rapids, Iowa, United States, 52403-1206 | |||||
| CCOP - Iowa Oncology Research Association | |||||
| Des Moines, Iowa, United States, 50309-1016 | |||||
| Siouxland Hematology-Oncology | |||||
| Sioux City, Iowa, United States, 51101-1733 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CentraCare Clinic | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68131 | |||||
| United States, North Dakota | |||||
| CCOP - Merit Care Hospital | |||||
| Fargo, North Dakota, United States, 58122 | |||||
| Medcenter One Health System | |||||
| Bismarck, North Dakota, United States, 58501 | |||||
| United States, Ohio | |||||
| CCOP - Toledo Community Hospital Oncology Program | |||||
| Toledo, Ohio, United States, 43623-3456 | |||||
| United States, Pennsylvania | |||||
| CCOP - Geisinger Clinic and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57105-1080 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
|
| Study ID Numbers: | CDR0000068281, NCCTG-N0043 |
| First Received: | November 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006467 |
| Health Authority: | United States: Federal Government |
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