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

Brown University

Status and phase

Completed

Phase 2

Conditions

Esophageal Cancer

Treatments

Drug: PPX with cisplatin and radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00522795

BrUOG-E-215

Details and patient eligibility

About

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

Full description

32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.

Enrollment

40 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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).