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Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
This study has been completed.
First Received: May 3, 2005   Last Updated: February 6, 2009   History of Changes
Sponsored by: Milton S. Hershey Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109941
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (progressive disease, stable disease, partial response, complete response) [ Designated as safety issue: No ]
  • Tumor size [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Depression [ Designated as safety issue: No ]
  • Opioid growth factor markers [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2003
Detailed Description:

OBJECTIVES:

Primary

  • Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in patients with advanced unresectable pancreatic cancer.

Secondary

  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.
  • Determine the pain control, depression, and nutritional status of patients treated with this drug.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of pancreatic cancer

    • Advanced, unresectable disease
  • Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or fluorouracil) for pancreatic cancer
  • Measurable disease by radiography
  • No primary CNS tumors or known brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 3,500/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 4.0 mg/dL (stents allowed)
  • PT or INR ≤ 2 seconds over control OR ≤ 1.8 (unless on warfarin)

Renal

  • BUN ≤ 30 mg/dL (hydrated)
  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No congestive heart failure
  • No symptoms of coronary artery disease
  • No cardiac arrhythmia
  • No poorly controlled hypertension
  • No myocardial infarction within the past year
  • No abnormal EKG
  • No other unstable cardiovascular disease
  • Pulse 60-110 beats/minute
  • Systolic blood pressure 90-170 mm Hg

Pulmonary

  • No asthma
  • No chronic obstructive pulmonary disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Sodium ≥ 130 mmol/L
  • Potassium ≥ 3.2 mmol/L
  • No serious infection requiring antibiotics within the past 2 weeks
  • No poorly controlled diabetes

    • Glucose 60-300 mg/dL
  • No seizure disorders
  • No fever > 37.8° C
  • No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent oral steroids

    • Concurrent topical steroids for dermatologic conditions allowed
    • Concurrent inhaled steroids for asthma allowed

Radiotherapy

  • Prior radiotherapy allowed
  • No concurrent radiotherapy

Surgery

  • At least 4 weeks since prior significant surgery and recovered
  • Prior Whipple procedure allowed

Other

  • No other concurrent antitumor medication
  • No other concurrent immunosuppressive agents (e.g., azathioprine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109941

Locations
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: Jill P. Smith, MD Milton S. Hershey Medical Center
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 03, 2009