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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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