Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Metastatic Gastric Cancer; Advanced Unresectable Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: BAY 43-9006; docetaxel; cisplatin
Intervention description: Given orally; Given IV; Given IV
Intervention MeSH terms: Cisplatin; Docetaxel; Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sorafenib; Docetaxel; Cisplatin; gastric cancer; gastroesophageal junction adenocarcinoma

Summary:

      This phase II trial is studying how well giving sorafenib together with docetaxel and
      cisplatin works in treating patients with metastatic or locally advanced gastric or
      gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking
      blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more
      tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have measurable, histologically confirmed, advanced unresectable or
             metastatic gastric or GEJ adenocarcinoma; imaging studies must be conducted within 4
             weeks of study entry

          -  For patients with GEJ adenocarcinoma, the tumor location should be specified using the
             Siewert classification used in other NCI-sponsored Phase II studies in these disease
             sites

          -  Patients must have an ECOG performance status of 0-1

          -  Patients may have had adjuvant chemotherapy or chemoradiation therapy, with or without
             5-Fluorouracil if the treatment was performed more than 6 months before any evidence
             of recurrent or metastatic disease

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Must have the following baseline laboratory values obtained within 2 weeks of
             registration:

               -  Absolute Granulocyte Count >= 1,500/mm^3

               -  Platelet Count >= 100,000/mm^3

               -  White Blood Count >= 3,000/mm^3

               -  Serum Creatinine <= 1.5 mg/dl

               -  Total Bilirubin <= 2.0 mg/dl

               -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline
                  phosphatase (Alk phos) <= 2.5 x upper limit of normal

          -  Patients must be able to take oral medication without crushing, dissolving or chewing
             tablets

        Exclusion Criteria:

          -  Prior radiotherapy, chemotherapy or investigational therapies, particularly inhibitors
             of tyrosine Kinases, signal transduction or angiogenesis in the treatment for their
             recurrent and/or metastatic gastric or GEJ adenocarcinoma

          -  Receiving any other investigational agents

          -  Being pregnant or breast-feeding; all females of childbearing potential must have a
             blood or urine test within 2 weeks prior to registration to rule out pregnancy

          -  HIV-positive patients receiving combination antiretroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with BAY 43-9006

          -  Brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to BAY 43-9006

          -  Acute active infection with significant clinical intervention per physician's
             discretion

          -  Previous or concurrent malignancies are not allowed, except:

               -  Non-melanoma skin cancer and in situ cervical cancer

               -  Treated cancer from which the patient has been continuously disease-free for more
                  than five years

          -  Other uncontrolled intercurrent illnesses including, but not limited to: uncontrolled
             hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia or psychiatric illness/addictive disorders that would limit compliance with
             study requirements

          -  Evidence of bleeding diathesis

          -  Concurrent cytochrome P450 enzyme-inducing anti-epileptic drugs:

               -  Phenytoin

               -  Carbamazepine

               -  Phenobarbital

               -  Rifampin

               -  St. John's Wort