Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: ISIS 2503 (Drug); gemcitabine hydrochloride (Drug); antisense therapy (Procedure); chemotherapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Steven R. Alberts, MD, Study Chair, Affiliation: Mayo Clinic
Summary
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.
Clinical Details
Official title: Phase II Trial of Gemcitabine and ISIS 2503 in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Study design: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
Locations and Contacts
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
CentraCare Clinic, Saint Cloud, Minnesota 56303, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States
CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States
Medcenter One Health System, Bismarck, North Dakota 58501, 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 - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2001
Last updated: December 15, 2007
|
