A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer

Inclusion Criteria:

- Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal
junction squamous cell or adenocarcinoma

- Measurable or evaluable disease per RECIST within 28 days prior to being registered
on protocol therapy.

- No more than one prior chemotherapy regimen for locally advanced or metastatic
disease is allowed.

- Written informed consent and HIPAA authorization for release of personal health
information. NOTE: HIPAA authorization may be included in the informed consent or
obtained separately.

- Age > 18 years.

- Females of childbearing potential and males must be willing to use an effective
method of contraception (hormonal or barrier method of birth control; abstinence)
while on treatment and for 3 month period thereafter.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for protocol therapy. Subjects are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
postmenopausal.

- Females must not be breastfeeding.

- Must be willing to comply with study and follow up procedures.

Exclusion Criteria:

- No history of inadequately controlled hypertension (SBP > 150 or DBP > 100) on a
standard regimen of antihypertensive therapy.

- No prior treatment with VEGF inhibitor, EGFR inhibitor, or other anti-angiogenic
agent.

No serious, non-healing wound, ulcer, or bone fracture.

- No history of or current hemoptysis.

- No history of TIA or stroke within 12 months prior to registration for protocol
therapy.

- No evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT.

- No chronic anti-coagulation treatment.

- No history of central nervous system or brain metastases.

- No history of any major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to registration for protocol therapy, or anticipation of
need for major surgical procedure during the course of protocol therapy.

- No history of any minor surgical procedures such as fine needle aspirations or core
biopsies within 7 days prior to registration for protocol therapy.

- No history of clinically significant peripheral neuropathy, i.e., Grade > 3
neuromotor or neurosensory toxicity as defined by NCI CTCAE v 3.0.

- No known history of adrenal insufficiency documented by ACTH stimulation testing.

- No prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), obtained
within 28 days prior to being registered for protocol therapy.

- No other active cancers

- No clinically significant infections as judged by the treating investigator.

- No history of a seizure disorder.

- No known history of hypersensitivity to paclitaxel.

- No CYP3A4 inducers and inhibitors allowed within 14 days prior to registration on
protocol therapy and while receiving the protocol therapy.