| Official Title: |
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A Phase II Study of Low-Dose Upper Abdominal Radiation Therapy (UART) as a Chemosensitizer in Patients with Locally Advanced or Metastatic Pancreatic Tumors |
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| Investigator: |
William Regine, M.D. |
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| Summary: |
Objectives:
To determine the objective response rate (RECIST criteria) of full dose gemcitabine combined with low-dose upper abdominal radiation therapy (UART) in patients with metastatic and locally advanced pancreatic cancer.( Phase II |
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| Disease site: |
Gastrointestinal,Pancreas |
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| Disease stage: |
Histologically confirmed locally advanced or metastatic tumors of the pancreas. Patients may also be Stage IV with metastatic disease to the liver. Patients with bone and/or lung metastasis may be included at the investigators discretion. |
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| Condition: |
Histologically confirmed locally advanced or metastatic tumors of the pancreas |
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| Intervention: |
Chemotherapy with Gemcitabine and LD-UART (Low Dose Upper Abdominal Radiation Therapy) |
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| Phase: |
II |
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| Study number: |
GCC 0319 |
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Eligibility*
(inclusion criteria) |
- Patients are eligible if they have newly diagnosed histologically confirmed locally advanced or metastatic tumors of the pancreas. Patients must be felt to be unresectable by surgical criteria or felt to be medically inoperable. Patients may also be Stage IV with metastatic disease to the liver. Patients with bone and/or lung metastasis may be included at the investigators discretion
- Patients must have measurable disease by CT scan.
- Patients must be able to give informed consent.
- Patients must be older than 18 years of age.
- Patients should have adequate bone marrow, renal, and hepatic function including:
- Bilirubin < 1.25 x institutional normal
- LDH, SGPT, SGOT, and alkaline phosphatase < 3 x institutional normal
- Serum creatinine less than or equal to 3 mg/dl.
- Absolute neutrophil count of > 1500
- Hemoglobin > 9 gm per dl
- Platelet count > 100,000
- WBC > 3000 cells per mcl
- Women of child-bearing potential must be agreeable to adequate contraception.(hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.)
- Patients must have a Karnofsky performance status of more than or equal to 60 or Zubrod less than or equal to 2.
- Life expectancy of at least 3 months
- May have had a second malignancy or multiple malignancies if adequately controlled by clinical means. Patients with more than one type of cancer must be cleared by the principal investigator
- Patients must be at least 1 week from any major operative procedure
- Patients may have brain metastasis if these brain metastasis are well controlled by usual clinical criteria and if the life expectancy is at least 3 months. Any patient with brain metastasis must be cleared by the principal investigator
(exclusion criteria)
- Active infection requiring IV or PO antibiotics at the time of entry
- Cerebral metastasis which have not been adequately controlled
- Significant malnutrition, cachexia, inundation or inability to give informed consent by clinical assessment
- Concurrent chemotherapy not prescribed in this protocol
- Any significant medical problems such as diabetes, cardiomyopathy or hypertension which is not reasonably controlled.
- Prior radiation or chemotherapy.
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Contact Person
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Nancy Kennedy, RN 410-328-2513
Galina Tucker, MD, CCRC 410-328-7586
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| * Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823. |
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