Sutent + Taxol for Advanced Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Sunitinib malate; Paclitaxel
Intervention description: Sunitinib malate 37.5 mg orally, daily; Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Intervention MeSH terms: Paclitaxel; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and
      has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens.
      Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when
      combined with chemotherapy, as demonstrated with other regimens in similar settings. We
      believe that the combination of paclitaxel and sunitinib malate offer great promise in the
      treatment of advanced esophageal cancer.
    

Eligibility criteria:

        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 (Systolic Blood Pressure > 150 or
             Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.

          -  No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal
             growth factor receptor (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 transient ischemic attack (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 adrenocorticotropic hormone
             (ACTH) stimulation testing.

          -  No prolonged corrected QT (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.