Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: RAV12; Gemcitabine
Intervention description: RAV12 at 0.375 mg/kg weekly escalated to 0.75 mg/kg weekly, intravenously.; 1000 mg/m2 weekly, intravenously
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage IV pancreatic cancer; recurrent pancreatic cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving RAV12 together with gemcitabine may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying the side effects and best dose of monoclonal
      antibody RAV12 when given together with gemcitabine in treating patients with metastatic
      pancreatic cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Metastatic disease

                    -  No prior therapy for metastatic disease (except prior adjuvant chemotherapy
                       and/or radiotherapy)

          -  At least 1 radiographically measurable site of disease ≥ 2 cm in the largest dimension
             by traditional CT technique or ≥ 1 cm by spiral CT scan (per RECIST)

          -  No known history of current or prior central nervous system (CNS) metastatic disease

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times upper limit of
             normal (ULN)

          -  Alkaline phosphatase and γ-glutamyltransferase ≤ 2.5 times ULN

          -  Amylase and lipase ≤ 1.5 times ULN

          -  Total bilirubin ≤ 1.5 times ULN

          -  Creatinine < 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be available for study-related treatments and assessments at the treating
             institution

          -  No known hypersensitivity to any component of gemcitabine hydrochloride

          -  No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any
             excipient contained in the drug formulation

          -  No other primary malignancy that has been in remission for ≤ 3 years except treated
             nonmelanoma skin cancer, biopsy-confirmed carcinoma in situ of the cervix, squamous
             intraepithelial lesion on Papanicolaou smear, localized prostate cancer with Gleason
             score < 6, or resected melanoma in situ

          -  No other primary malignancy that has a generally accepted recurrence risk ≥ 10%

          -  No active viral, bacterial, or systemic fungal infection requiring parenteral
             treatment within 4 weeks of enrollment

          -  No history of chronic or recurrent infections that require continuous use of
             antiviral, antifungal, or antibacterial agents

          -  No serious underlying medical condition that would impair the patient's ability to
             receive or tolerate the planned treatment at the investigational site, including
             significant pulmonary compromise or heart disease of New York Heart Association class
             III or IV

          -  No dementia or altered mental status that would preclude sufficient understanding to
             provide informed consent

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 4 weeks since prior major surgery

          -  More than 4 weeks since prior and no other concurrent investigational agents

          -  More than 1 week since prior oral antiviral, antifungal, or antibacterial therapy

          -  No concurrent immunosuppressive medications, steroids (except steroid inhaler,
             ophthalmic solution, nasal spray, or a stable dose of ≤ 10 mg/day of oral prednisone
             or equivalent), other antineoplastic therapy, or antitumor vaccinations

          -  Monoclonal antibody treatment for non-cancer indications must be completed at least 3
             half lives from study entry

          -  No concurrent prophylactic hematologic growth factors

          -  No concurrent megavitamin therapy

          -  No concurrent bisphosphonates