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Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer

OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced
adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of
response in these patients receiving this regimen. III. Characterize the safety profile of
ISIS 2503 at the recommended phase II dose and schedule in these patients.

OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every
21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas
that is considered inoperable Measurable disease with at least 1 lesion measuring at least
2 cm in widest diameter identifiable on CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal:
Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective barrier contraception during and for 6 months
after study No underlying disease state associated with active bleeding No active
infection requiring therapy No other prior malignancy within the past 5 years except
nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for pancreatic
cancer Chemotherapy: No prior chemotherapy for pancreatic cancer except for fluorouracil
and/or gemcitabine administered as a radiosensitizer No other concurrent chemotherapy for
pancreatic cancer Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy
allowed provided indicator lesions not within prior radiation port Recovered from toxicity
No concurrent radiotherapy for pancreatic cancer Surgery: See Disease Characteristics
Other: No concurrent anticoagulation therapy with heparin No other concurrent approved or
experimental cancer therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

James A. Posey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Norris Cotton Cancer Center Lebanon, New Hampshire  03756