Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer Read More

Inclusion Criteria:

• Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
• Patients may have celiac adenopathy
• There must be no evidence of distant organ metastases
• No prior chemotherapy or radiation for esophageal cancer
• Patients must be > 18 years of age, and non pregnant
• Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2.0 and bilirubin < 1.5 x ULN-ECOG performance status 0-1.
• Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients 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. Pregnant or lactating females are not eligible
• No contraindications to esophagectomy
• Signed informed consent

Exclusion Criteria:

• Active or uncontrolled infection
• Patients must not have other coexistent medical condition that would preclude protocol therapy.
• Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).