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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

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

OUTLINE: This is a multi-center study.

Treatment will be administered on an outpatient basis. Chemotherapy will be administered in
a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate
(plus the time required to recover if toxicity is encountered) is defined as a cycle.

- Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

- Sunitinib malate 37.5 mg orally, daily.

After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib
malate until disease progression, unacceptable toxicity, or physician discretion.

Performance Status: ECOG performance status 0 to 2

Life expectancy: Not specified


- INR < 1.2

- PTT < 1.5 x Upper Limit of Normal (ULN)

- Platelets > 100 K/mm3

- Hemoglobin > 8 g/dL

- Absolute Neutrophil Count (ANC) > 1.0 K/mm3


- Aspartate transaminase [AST] ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation
is due to known liver metastases.

- Alanine transaminase [ALT] ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is
due to known liver metastases.

- Total bilirubin < 2.0 x ULN


- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault
formula) > 50 cc/min


- No history of unstable angina, myocardial infarction, coronary artery bypass grafting
surgery within 12 months prior to registration for protocol therapy. Patients may be
on anti-anginal medications, but must be stable on those medications for at least 6

- No history of New York Heart Association class II or greater congestive heart failure.


- Not specified

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

- 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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Nasser Hanna, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group


United States: Institutional Review Board

Study ID:

HOG GI06-112



Start Date:

August 2008

Completion Date:

March 2010

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Northwestern University Feinberg School of Medicine Chicago, Illinois  60611
Arnett Cancer Care Lafayette, Indiana  47904
Northern Indiana Cancer Research Consortium South Bend, Indiana  
Medical & Surgical Specialists, LLC Galesburg, Illinois  61401
Cancer Care Center Of Southern Indiana Bloomington, Indiana  47403
Horizon Oncology Center Lafayette, Indiana  47905
Oncology Hematology Associates of SW Indiana Evansville, Indiana  47714
Providence Medical Group Terre Haute, Indiana  47802
Medical Consultants, P.C. Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, Inc Fort Wayne, Indiana  46815
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
IN Onc/Hem Associates Indianapolis, Indiana  46202
Monroe Medical Associates Munster, Indiana  46321
Rush-Presbyterian St. Luke's Medical Center Chicago, Illinois  60612
Ireland Cancer Center - University Hospitals of Cleveland Cleveland, Ohio  44106