Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: rhuMAB-VEGF; docetaxel
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such
      as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing
      or die. Combining bevacizumab with docetaxel may kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well
      they work compared to bevacizumab alone in treating patients with metastatic pancreatic
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the pancreas

               -  Metastatic disease

          -  Unidimensionally measurable disease outside of the pancreas

               -  At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by
                  spiral CT scan

          -  Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic
             disease unless disease has recurred within 6 months after treatment with neoadjuvant
             or adjuvant gemcitabine-containing therapy

          -  No brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 9.0 g/dL (transfusion allowed)

          -  No bleeding diathesis or coagulopathy

        Hepatic

          -  Bilirubin no greater than upper limit of normal (ULN)

          -  AST and ALT no greater than 1.5 times ULN

          -  INR no greater than ULN

          -  PTT no greater than ULN

        Renal

          -  Creatinine no greater than 2.0 mg/dL

          -  No clinically significant renal impairment

          -  Urine protein:creatinine ratio ≥ 1.0

        Cardiovascular

          -  No prior myocardial infarction

          -  No prior stroke

          -  No clinically significant cardiovascular disease

          -  No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on
             medication)

          -  No unstable angina

          -  No New York Heart Association class II-IV congestive heart failure

          -  No serious cardiac dysrhythmia requiring medication

          -  No peripheral vascular disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history or evidence of CNS disease (e.g, primary brain tumor or seizures not
             controlled with standard medical therapy)

          -  No other medical condition that would preclude study participation

          -  No psychiatric condition that would preclude study participation

          -  No other prior or concurrent malignancy that would preclude study participation

          -  No significant traumatic injury within the past 28 days

          -  No serious, nonhealing wound, ulcer, or bone fracture

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent prophylactic granulocyte or platelet growth factors

        Chemotherapy

          -  See Disease Characteristics

          -  More than 4 weeks since prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 4 weeks since prior radiotherapy

        Surgery

          -  More than 7 days since prior fine needle aspirations or core biopsies

          -  More than 28 days since prior surgery (except closed biopsy or access port placement)

          -  More than 28 days since prior open biopsy

          -  No concurrent surgery

        Other

          -  More than 4 weeks since prior experimental drug study participation

          -  More than 4 weeks since prior investigational drugs

          -  No other concurrent experimental drug study participation