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Sutent + Taxol for Advanced Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Nasser Hanna, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00730353
First received: August 4, 2008
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Esophageal Cancer
Drug: Sunitinib malate
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Progression Free Survival Rate at 24 Weeks [ Time Frame: 24 weeks ]
    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, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ]
    To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

  • Overall Survival [ Time Frame: 12 months ]
    To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma

  • Progression-Free Survival [ Time Frame: 12 months ]
    To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

  • Toxicity Profile [ Time Frame: 16 months ]
    Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.


Enrollment: 28
Study Start Date: August 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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.
Drug: Sunitinib malate
Sunitinib malate 37.5 mg orally, daily
Drug: Paclitaxel
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

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 (Eastern Cooperative Oncology Group) performance status 0 to 2

Life expectancy: Not specified

Hematopoietic:

  • International Normalized Ratio (INR) < 1.2
  • Partial Thromboplastin Time (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730353

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
IN Onc/Hem Associates
Indianapolis, Indiana, United States, 46202
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Monroe Medical Associates
Munster, Indiana, United States, 46321
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Ohio
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Hoosier Cancer Research Network
Pfizer
Investigators
Study Chair: Nasser Hanna, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
Publications:
Responsible Party: Nasser Hanna, M.D., Professor, IU School of Medicine, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00730353     History of Changes
Other Study ID Numbers: HOG GI06-112
Study First Received: August 4, 2008
Results First Received: April 29, 2016
Last Updated: January 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Sunitinib
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2017