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Sutent + Taxol for Advanced Esophageal Cancer

Information source: Hoosier Cancer Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer

Intervention: Sunitinib malate (Drug); Paclitaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoosier Cancer Research Network

Official(s) and/or principal investigator(s):
Nasser Hanna, M.D., Study Chair, Affiliation: Hoosier Cancer Research Network

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.

Clinical Details

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

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

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.

Secondary outcome:

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.

Detailed description: 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 Hematopoietic:

- 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

Hepatic:

- 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

Renal:

- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault

formula) > 50 cc/min Cardiovascular:

- 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 months.

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

Pulmonary:

- Not specified

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (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.

Locations and Contacts

Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, United States

Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois 60612, United States

Medical & Surgical Specialists, LLC, Galesburg, Illinois 61401, United States

Cancer Care Center of Southern Indiana, Bloomington, Indiana 47403, United States

Oncology Hematology Associates of SW Indiana, Evansville, Indiana 47714, United States

Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana 46815, United States

IN Onc/Hem Associates, Indianapolis, Indiana 46202, United States

Indiana University Simon Cancer Center, Indianapolis, Indiana 46202, United States

Arnett Cancer Care, Lafayette, Indiana 47904, United States

Horizon Oncology Center, Lafayette, Indiana 47905, United States

Medical Consultants, P.C., Muncie, Indiana 47303, United States

Monroe Medical Associates, Munster, Indiana 46321, United States

Northern Indiana Cancer Research Consortium, South Bend, Indiana 46601, United States

Providence Medical Group, Terre Haute, Indiana 47802, United States

Ireland Cancer Center - University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Additional Information

Hoosier Oncology Group Homepage

Related publications:

Schmitt JM, Sommers SR, Fisher W, Ansari R, Robin E, Koneru K, McClean J, Liu Z, Tong Y, Hanna N. Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group. J Thorac Oncol. 2012 Apr;7(4):760-3. doi: 10.1097/JTO.0b013e31824abc7c.

Starting date: August 2008
Last updated: April 21, 2011

Page last updated: August 23, 2015

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