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Phase II Trial of Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer, Gastroesophageal Junction Cancer

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Trial Information

Phase II Trial of Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer

Inclusion Criteria:

- Patients must have histologically proven or cytologically confirmed esophageal cancer
(squamous cell carcinoma or adenocarcinoma) or adenocarcinoma of the gastroesophageal
(GE) junction documented at MSKCC.

- Metastatic disease measurable on a CT or MRI scan. Locally recurrent disease that is
not amenable to potentially curative surgery or radiation therapy is also allowed.
Lesions must be ≥ 10 mm in size. The primary tumor is not considered measurable
disease. Recurrent or metastatic lesions within a prior radiation field are
acceptable as long as disease has progressed in the radiation field by RECIST
criteria. The same imaging modality performed at baseline (CT or MRI) will be
repeated at subsequent imaging.

- Patients are allowed to have a maximum of two prior chemotherapy regimens for
metastatic disease. Patients are allowed to have a maximum of three prior regimens if
they also previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy.
The last treatment must have been administered > 3 weeks prior to initiation of
therapy with sorafenib.

- Pathologic tissue must be available for immunohistochemistry (IHC) staining for
phosphorylated extracellular signal-regulated kinase (pERK). Both patients with and
without pERK staining are eligible for treatment. Submission of slides and IHC
testing for pERK may be done during the course of therapy and are not required prior
to protocol therapy.

- Age ≥ 18 years.

- Life expectancy > 3 months.

- Karnofsky performance status ≥ 60%.

- Patients must have the ability to comprehend and willingness to sign an informed
consent document.

- At baseline, patients must have normal organ and marrow function as defined:

- Adequate bone marrow, liver and renal function as assessed by the following:

- Hemoglobin ≥ 9.0 g/dl

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100,000/mm3

- Total bilirubin < or = to 1.5 times ULN

- ALT and AST < or = to 2.5 times the ULN ( < or = to 5 x ULN for patients
with liver involvement)

- Creatinine < or = to 1.5 times ULN

Exclusion Criteria:

- Patients who have not recovered from adverse events related to therapy administered >
3 weeks earlier. This does not include hemoglobin or other hematologic or laboratory

- Patients may not be receiving any other investigational agents.

- Prior therapy with sorafenib-related compounds or compounds of similar biologic or
chemical components, including compounds targeting VEGF, VEGF-R or RAF kinase.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, greater than New York Heart Association (NYHA) Class II congestive heart
failure, unstable or new onset angina pectoris or myocardial infarction within the
past six months, unstable arrhythmia, or psychiatric illness/social situation, e.g.,
severe schizophrenia, that would limit compliance with study requirements. Patients
with chronic arrhythmias, such as paroxysmal atrial fibrillation or paroxysmal
supraventricular tachycardia, are eligible.

- Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic
blood pressure > 90 mmHg, despite optimal medical management.

- Thrombotic or embolic event, including cerebrovascular accident or transient ischemic
attack within the past six months. Patients with prior deep vein thromboses or
pulmonary emboli on a stable anticoagulation regimen will be eligible for enrollment.

- Any factor that would significantly interfere with the inability to consume or absorb
an oral medication, e.g. severe nausea/vomiting not controlled by an aggressive
anti-emetic regimen, grade 3/4 dysphagia, extensive small bowel resection or active
inflammatory bowel disease leading to chronic malabsorption. Patients with enteral
feeding tubes are eligible as sorafenib can be crushed.

- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C

- Patients with any other concurrent disease which, in the judgment of the
investigator, would make the patient inappropriate for participation in the study.

- Patients who are taking St. John's wort or rifampin (as there may be drug-drug
interactions with sorafenib.

- Patients with known brain metastases or meningeal carcinomatosis are excluded.
Patients with neurological symptoms must undergo a CT scan/MRI of the brain to
exclude brain metastasis.

- Pregnant women are excluded because sorafenib has the potential for teratogenic or
abortifacient effects. Female patients must either not be of childbearing potential
or must have a negative pregnancy test ≤ 7 days prior to treatment. Female patients
are considered not of childbearing potential if they are surgically sterile (they
have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or
if they are post-menopausal. Men must use effective birth control if their partners
are of child-bearing potential.

- No other malignancy is allowed except for adequately treated carcinoma in-situ of the
cervix, superficial transitional cell carcinoma of the bladder or basal/squamous cell
skin cancer. Other cancers are permissible if the patient has been disease free for ≥
3 years.

- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of
study drug.

- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of
study drug.

- Serious non-healing wound, ulcer, or bone fracture.

- Evidence or history of bleeding diathesis or coagulopathy.

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study drug.

- Known or suspected allergy to sorafenib or any agent given in the course of this

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the 2-month progression-free survival (PFS) of sorafenib in patients with metastatic or recurrent esophageal and gastroesophageal (GE) junction cancer.

Outcome Time Frame:

after the first 4 weeks on study, at eight weeks, and then every 8 weeks thereafter

Safety Issue:


Principal Investigator

David Ilson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

June 2013

Related Keywords:

  • Esophageal Cancer
  • Gastroesophageal Junction Cancer
  • BAY 43-9006 (SORAFENIB)
  • 09-016
  • Nexavar®.
  • Esophageal Diseases
  • Esophageal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021