Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Milton S. Hershey Medical Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00109941 |
RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Biological: opioid growth factor |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II |
Estimated Enrollment: | 50 |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive opioid growth factor ([Met^5]-enkephalin) IV over 45 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 weeks during study treatment, and at the completion of study treatment.
Patients are followed weekly for survival.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of pancreatic cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No poorly controlled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent oral steroids
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 |
Study Chair: | Jill P. Smith, MD | Milton S. Hershey Medical Center |
Study ID Numbers: | CDR0000425404, PSCI-96219, PSCI-HY96-219 |
Study First Received: | May 3, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00109941 History of Changes |
Health Authority: | United States: Federal Government |
recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Central Nervous System Depressants Endocrine System Diseases Recurrence Digestive System Diseases Gastrointestinal Neoplasms |
Pancreatic Diseases Mitogens Endocrinopathy Analgesics Peripheral Nervous System Agents Analgesics, Opioid Endocrine Gland Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Pancreatic Neoplasms Physiological Effects of Drugs Mitosis Modulators Central Nervous System Depressants Endocrine System Diseases Pharmacologic Actions Neoplasms Neoplasms by Site |
Digestive System Diseases Sensory System Agents Therapeutic Uses Pancreatic Diseases Mitogens Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Endocrine Gland Neoplasms |