NCT00730353

Sutent + Taxol for Advanced Esophageal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sunitinib malate	Sunitinib malate 37.5 mg orally, daily
DRUG	Paclitaxel	Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-08-08
• Last updated: 2017-03-16
• Results posted: 2017-03-16

Locations

15 sites across 1 country: United States