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

This study is currently recruiting participants.

Verified by Brown University, July 2008

Sponsors and Collaborators:	Brown University University of Maryland Greenebaum Cancer Center
Information provided by:	Brown University
ClinicalTrials.gov Identifier:	NCT00522795

Purpose

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

Condition	Intervention	Phase
Esophageal Cancer	Drug: Paclitaxel Poliglumex and Cisplatin	Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Paclitaxel Paclitaxel Poliglumex

U.S. FDA Resources

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

Further study details as provided by Brown University:

Primary Outcome Measures:

Primary:pathologic complete response rate

Secondary Outcome Measures:

Secondary: toxicity

Estimated Enrollment:	32
Study Start Date:	August 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00522795

Contacts

Contact: Teresa a kennedy, RN, CCRA

401-383-3000

Teresa_Kennedy@Brown.edu

Locations

United States, Rhode Island
Lifespan Hospitals	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Teresa A Kennedy, RN 401-383-3000 Teresa_Kennedy@brown.edu
Principal Investigator: Howard safran, MD

Sponsors and Collaborators

Brown University

University of Maryland Greenebaum Cancer Center

Investigators

Principal Investigator:

Howard Safran, MD

Brown University

More Information

Responsible Party:	Brown University Oncology Group ( Howard Safran,MD )
Study ID Numbers:	BrUOG-E-215
Study First Received:	August 28, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00522795
Health Authority:	United States: Food and Drug Administration

Keywords provided by Brown University:

Esophageal Cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Cisplatin
Esophageal disorder
Paclitaxel
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009