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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

Phase 2
19 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

BrUOG-E-215-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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete pathologic response as determined at

Outcome Time Frame:

At Surgery approximately 4weeks after last treatment

Safety Issue:


Principal Investigator

Howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

April 2010

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Lifespan Hospitals Providence, Rhode Island  02903