Sutent + Taxol for Advanced Esophageal Cancer
Information source: Hoosier Oncology Group
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Esophageal Cancer
Intervention: Sunitinib malate (Drug); Paclitaxel (Drug)
Phase: Phase 2
Sponsored by: Hoosier Oncology Group
Official(s) and/or principal investigator(s):
Nasser Hanna, M.D., Study Chair, Affiliation: Hoosier Oncology Group
Nasser Hanna, M.D., Phone: 317.274.3515, Email: firstname.lastname@example.org
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.
Official title: A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
Study design: Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: 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.
To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.
To determine the toxicities for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.
To determine survival rates for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.
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] â‰¤ 2. 5 x ULN, or â‰¤ 5. 0 x ULN if the transaminase elevation
is due to known liver metastases.
- Alanine transaminase [ALT] â‰¤ 2. 5 x ULN, or â‰¤ 5. 0 x ULN if the transaminase elevation is
due to known liver metastases.
- Total bilirubin < 2. 0 x ULN
- Serum creatinine â‰¤ 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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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.
- 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.
Locations and Contacts
Nasser Hanna, M.D., Phone: 317.274.3515, Email: email@example.com
Medical & Surgical Specialists, LLC, Galesburg, Illinois 61401, United States; Recruiting
John McClean, M.D., Phone: 309-343-2262
Linda Ferry, R.N., Phone: 309-343-2262, Email: firstname.lastname@example.org
Indiana University Simon Cancer Center, Indianapolis, Indiana 46202, United States; Recruiting
Nasser Hanna, M.D., Phone: 317-274-3545, Email: email@example.com
Kerry Bridges, Phone: 317-274-2552, Email: firstname.lastname@example.org
Arnett Cancer Care, Lafayette, Indiana 47904, United States; Recruiting
Thomas Jones, M.D., Phone: 765-448-7500
Janice Welty, R.N., Phone: 765-448-7500, Email: email@example.com
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana 46815, United States; Recruiting
Sreenivasa Nattam, M.., Phone: 260-484-8830
Lesllie Edgar, R.N., Phone: 260-484-8830, Email: firstname.lastname@example.org
Horizon Oncology Center, Lafayette, Indiana 47905, United States; Recruiting
Wael Harb, M.D., Phone: 765-446-5111, Email: email@example.com
Linda Vaders, R.N., Phone: 765.446.5111, Email: firstname.lastname@example.org
Medical Consultants, P.C., Muncie, Indiana 47303, United States; Recruiting
William Fisher, M.D., Phone: 765-281-2174
Brenda Sloan, R.N., Phone: 765-254-4748, Email: email@example.com
Northern Indiana Cancer Research Consortium, South Bend, Indiana 46601, United States; Recruiting
Jose Bufill, M.D., Phone: 574-234-5123
Susan Haithcox, R.N., Phone: (574) 647-7977, Email: firstname.lastname@example.org
Oncology Hematology Associates of SW Indiana, Evansville, Indiana 47714, United States; Recruiting
Michael Titzer, M.D., Phone: 812-471-1200
Paige Wisnoski, Phone: 812-471-1200, Email: pwisnoski@OHAEV.com
Providence Medical Group, Terre Haute, Indiana 47802, United States; Recruiting
Sang Y Huh, M.D., Phone: 812-234-5707
Kim Villain, Phone: 812-234-5707, Email: email@example.com
Hoosier Oncology Group Homepage
Starting date: August 2008
Ending date: December 2011
Last updated: July 30, 2009