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

Completed · Phase 2

Conditions studied: Esophageal Cancer

In brief

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

Key facts

Study ID: NCT00522795
Run by: Brown University
People needed: 40
Starts: 2007-08-01
Expected to finish: 2010-04-01
Last updated by the study team: 2020-02-17

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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).

Where it is running

Lifespan Hospitals — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.