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

This study has been completed.
University of Maryland Greenebaum Cancer Center
Information provided by (Responsible Party):
howard safran, Brown University Identifier:
First received: August 28, 2007
Last updated: August 22, 2013
Last verified: August 2013

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

Condition Intervention Phase
Esophageal Cancer
Drug: PPX with cisplatin and radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

Resource links provided by NLM:

Further study details as provided by Brown University:

Primary Outcome Measures:
  • Complete Pathologic Response [ Time Frame: At Surgery approximately 4weeks after last treatment ] [ Designated as safety issue: No ]
    Per pathology review post surgery

Enrollment: 40
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PPX with cisplatin and radiation
PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation
Drug: PPX with cisplatin and radiation
weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
Other Name: Paclitaxel Poliglumex, Cisplatin and radiation

Detailed 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.


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Please refer to this study by its identifier: NCT00522795

United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
University of Maryland Greenebaum Cancer Center
Principal Investigator: Howard Safran, MD Brown University
  More Information

No publications provided

Responsible Party: howard safran, Principle Investigator, Brown University Identifier: NCT00522795     History of Changes
Other Study ID Numbers: BrUOG-E-215
Study First Received: August 28, 2007
Results First Received: May 21, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic processed this record on April 15, 2014