Sutent + Taxol for Advanced Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730353
• Other study ID #: HOG GI06-112
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2008
• Last updated: April 21, 2011
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cancer Care Center of Southern Indiana	Bloomington	Indiana
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rush-Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	Ireland Cancer Center - University Hospitals of Cleveland	Cleveland	Ohio
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
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

Sponsors (2)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Pfizer

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.		6 months	No
Secondary	To determine the toxicities for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.		6 months	Yes
Secondary	To determine survival rates for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma		6 months	No
Secondary	To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma.		6 months	No

External Links

•   Hoosier Oncology Group Homepage