Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Condition: Esophageal Cancer; Stomach Cancer
MeSH terms: Stomach Neoplasms
Intervention: Bevacizumab; Docetaxel; Cisplatin; Irinotecan
Intervention MeSH terms: Bevacizumab; Cisplatin; Docetaxel; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TPCA; Taxotere; Platinum; Avastin; Camptosar; gastric cancer

Summary:

      The purpose of this research study is to determine if the combination of docetaxel,
      cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric
      cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is
      believed to stop the formation of new blood vessels that carry nutrients to tumors.
      Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin
      and irinotecan are traditional chemotherapy agents that have been tested together in another
      clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this
      regimen will make the treatment more effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, unresectable esophageal or gastric carcinoma
             (carcinoma=adenocarcinoma or squamous cell carcinoma)

          -  Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed
             tomography (CT) scan or 2 cm or greater by other radiographic technique

          -  Lesions must be measurable in at least one dimension

          -  Bone lesions, ascites, and effusions are not measurable

          -  18 years of age or older

          -  ECOG performance status 0 or 1

          -  Life expectancy of at least 12 weeks

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate liver function

        Exclusion Criteria:

          -  Prior chemotherapy (except as part of pre- or post-operative therapy, completed more
             than 1 year prior to start day of this protocol)

          -  History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan,
             or drugs formulated with polysorbate 80

          -  Current, recent (within 4 weeks) or planned participation in an experimental drug
             study

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study

          -  Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or
             core biopsies within 7 days prior to Day 0 of study

          -  Myocardial infarction or stroke in past 6 months

          -  Blood pressure of > 150/100 mmHg

          -  Unstable angina

          -  New York Heart Association (NYHA) grade II or greater congestive heart failure

          -  Clinically significant peripheral vascular disease

          -  Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated
             transfusions

          -  Evidence of bleeding diathesis or coagulopathy

          -  Uncontrolled serious medical or psychiatric illness

          -  Uncontrolled diarrhea

          -  Peripheral neuropathy > grade 1

          -  Clinically apparent central nervous system metastases or carcinomatous meningitis

          -  Other active malignancy other than non-melanoma skin cancer or in situ cervical
             carcinoma.

          -  Urine protein: creatinine ratio of 1.0 or greater at screening

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 1

          -  Serious non-healing wound, ulcer, or bone fracture

          -  Pregnant or breast-feeding