Cisplatin, Irinotecan and Bevacizumab (PCA) Versus Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Condition: Esophageal Cancer; Gastric Cancer; Stomach Cancer
MeSH terms: Stomach Neoplasms
Intervention: Bevacizumab; Cisplatin; Irinotecan; Docetaxel
Intervention MeSH terms: Bevacizumab; Cisplatin; Docetaxel; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There is no clear standard of care for metastatic stomach or esophageal cancer in the United
      States. The purpose of this research study is to determine the differences between two
      regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA
      (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are
      traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign
      substance in the body). Bevacizumab is believed to stop the formation of new blood vessels
      that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been
      studied in patients with esophageal and gastric cancer, and we are trying to determine if one
      regimen will keep your cancer from growing and improve how long you can live.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, unresectable esophageal, GE junction or gastric
             adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable
             disease is not required.

          -  18 years of age or older

          -  ECOG Performance Status=2

          -  Life expectancy of 12 weeks or greater

          -  Adequate bone marrow, renal and liver function as outlined in the protocol.

          -  Men and women of childbearing potential must use adequate contraception

        Exclusion Criteria:

          -  Prior chemotherapy (except as part of pre- or post-operative therapy, completed at
             least 1 prior to start of this protocol).

          -  Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor

          -  Known history of allergy or hypersensitivity to Chinese hamster ovary products,
             polysorbate 80, or any of the study drugs

          -  Treatment or planned participation in an experimental drug study within 4 weeks of C1
             D1. Concurrent use of herbal medications or other alternative therapies

          -  Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or
             core biopsies, within 7 days of cycle 1 day 1

          -  Palliative radiation to 25% or less of bone marrow, must be completed > 2 weeks prior
             to day 1, palliative radiation to > 25% of bone marrow, must be completed > 4 weeks
             prior to day 1

          -  Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the
             past six months

          -  Inadequately controlled hypertension (defined as systolic blood pressure of >150mmHg
             and/or diastolic blood pressure of > 100mmHg). Initiation of antihypertensive
             medication is recommended, however adequate control of blood pressure must be
             documented prior to C1 D1

          -  No history of prior hypertensive crisis or hypertensive encephalopathy

          -  NYHA Grade II or greater congestive heart failure

          -  Clinically significant peripheral vascular disease

          -  Active bleeding from primary tumor

          -  Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis,
             portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on
             therapeutic anticoagulation may be enrolled provided they have been clinically stable
             on anticoagulation for a least 2 weeks prior to C1 D1.

          -  Uncontrolled serious medical or psychiatric illness

          -  Uncontrolled diarrhea

          -  Peripheral neuropathy

          -  No known brain or other CNS metastasis by history or clinical examination

          -  Other active malignancy other than non-melanoma skin cancer or in-situ cervical
             carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must
             have demonstrated no evidence of recurrence for at least 3 years

          -  Urine protein:creatinine ratio 1.0 or greater at screening

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             with 6 months of C1 D1

          -  Serious, non-healing wound, ulcer or bone fracture

          -  Pregnant or breast feeding

          -  Inability to comply with study and/or follow-up procedures

          -  History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or
             other serious chronic infection