Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
Condition: Pancreatic Carcinoma Non-resectable; Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: gemcitabine; Erlotinib; low dose fractionated radiotherapy
Intervention description: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.; Erlotinib 100mg or 150mg daily of each 21 day cycle; low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cancer; locally advanced; unresectable; metastatic pancreatic cancer

Summary:

      People with pancreatic cancer usually have a large amount of the cancer in the area of the
      pancreas and around it when they are diagnosed with it. Or their cancer has spread
      (metastasized)outside that area of the abdomen and is not able to be surgically removed
      (resected). For patients with metastatic disease, one standard treatment is the combination
      of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to
      getting gemcitabine alone. For patients with localized but unresectable disease, the standard
      treatment remains controversial. Early studies showed that chemotherapy and radiation
      together was better than either one used alone. The greatest benefit of external beam
      radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread.
      A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy
      usually have to be reduced sometimes by half.

      Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate
      the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in
      patients with locally advanced or limited metastatic pancreatic cancer. Patients will be
      enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib.

      For patients with locally advanced disease, this protocol also may help because most patients
      develop and die from spread to the liver and abdominal cavity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of adenocarcinoma of the pancreas that is not amenable
             to curative surgical resection. Patients with locally advanced unresectable disease
             and those patients with metastatic disease that can be encompassed in the radiation
             fields for this study (as assessed by treating radiation oncologist) are eligible.

          -  Patients may not have received any prior chemotherapy for locally advanced or
             metastatic pancreatic cancer. Prior adjuvant chemotherapy completed >1 year previously
             is allowed.

          -  Patients must be able to provide informed consent and HIPAA consent.

          -  Patients must be ≥18 years of age

          -  Adequate hematologic and organ function:

               -  ANC ≥ 1,000/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9.0/dL

               -  Bilirubin: ≤1.5X ULN

               -  ALT/AST < 3.0 X upper limit of normal

               -  Serum Creatinine: WNL

               -  Albumin > 2.5 g/dL

          -  Measurable and non-measurable disease are permitted

          -  ECOG performance status 0-1

          -  Patients must be able to swallow oral medications

          -  Patients must be able to comply with study and follow up procedures

        Exclusion Criteria:

          -  No prior radiation therapy to the abdomen.

          -  Patients must not have any other active illness (e.g. active/uncontrolled infection,
             uncontrolled cardiac disease, etc.) that would preclude safe therapy in the judgment
             of the treating physicians. Patients may be enrolled while still on antibiotics as
             long as clinical signs of active infection are absent.

          -  Patients with concurrent active malignancy requiring therapy are not eligible.
             Patients with a history of malignancy within any timeframe not requiring ongoing
             therapy are eligible.