Sutent + Taxol for Advanced Esophageal Cancer

NCT ID: NCT00730353

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-03-31

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.

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

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sunitinib malate

Intervention Type: DRUG

Sunitinib malate 37.5 mg orally, daily

Paclitaxel

Intervention Type: DRUG

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

Interventions

Sunitinib malate

Sunitinib malate 37.5 mg orally, daily

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Hoosier Cancer Research Network

OTHER

Sponsor Role: lead

Responsible Party

Nasser Hanna, M.D.

Professor, IU School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasser Hanna, M.D.

Role: STUDY_CHAIR

Hoosier Cancer Research Network

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, United States

IN Onc/Hem Associates

Indianapolis, Indiana, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Arnett Cancer Care

Lafayette, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Medical Consultants, P.C.

Muncie, Indiana, United States

Monroe Medical Associates

Munster, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Providence Medical Group

Terre Haute, Indiana, United States

Ireland Cancer Center - University Hospitals of Cleveland

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22425927 (View on PubMed)

Related Links

http://www.hoosieroncologygroup.org

Hoosier Oncology Group Homepage

Other Identifiers

HOG GI06-112

Identifier Type: -

Identifier Source: org_study_id