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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborator: University of Maryland Greenebaum Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel; Paclitaxel poliglumex

Criteria

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).