Sutent + Taxol for Advanced Esophageal Cancer

NCT00730353 | Completed Phase 2 Results DMC

• 1 other identifier: HOG GI06-112
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Rate at 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

  24 weeks

Secondary Outcomes (4)

• Response Rate

  6 months

• Overall Survival

  12 months

• Progression-Free Survival

  12 months

• Toxicity Profile

  16 months

Study Arms (1)

1

EXPERIMENTAL

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; Drug: Paclitaxel

Interventions

Sunitinib malate DRUG

Sunitinib malate 37.5 mg orally, daily

1

Paclitaxel DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Pfizer: collaborator

Study Sites (15)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

IN Onc/Hem Associates

Indianapolis, Indiana, 46202, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Monroe Medical Associates

Munster, Indiana, 46321, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Ireland Cancer Center - University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 22425927 BACKGROUND

Related Links

• Hoosier Oncology Group Homepage

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Sunitinib; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

Statistical power is based on 26 evaluable patients; However, all objectives other than the primary objective were based on 23 evaluable patients.

Results Point of Contact

• Title: Nasser Hanna, M.D.
• Organization: Hoosier Oncology Group

nhanna@iupui.edu

317-274-3515

Study Officials

• Nasser Hanna, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, IU School of Medicine

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 16, 2017
• Results First Posted: March 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)