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

February 13, 2020 updated by: howard safran, Brown University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Paclitaxel Poliglumex, Cisplatin and radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Pathologic Response
Time Frame: At Surgery approximately 4weeks after last treatment
Per pathology review post surgery
At Surgery approximately 4weeks after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

University of Maryland Greenebaum Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BrUOG-E-215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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