Clinical trial NCT00730353
Conditions: Esophageal Cancer
Sponsor: Hoosier Cancer Research Network
Start date: 2008-08-01; Completion date: 2010-03-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

Arms: arm 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.
Interventions: intervention 1: Sunitinib malate intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Sunitinib malate 37.5 mg orally, daily intervention 2: Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

Protocol documents: