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



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:3/22/2019
Start Date:August 2007
End Date:April 2010

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BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

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

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.

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).
We found this trial at
1
site
Providence, Rhode Island 02903
?
mi
from
Providence, RI
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