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

This study has been completed.
Sponsor:
Collaborator:
University of Maryland Greenebaum Cancer Center
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00522795
First received: August 28, 2007
Last updated: August 22, 2013
Last verified: August 2013
  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: 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.

  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

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

No publications provided

Responsible Party: howard safran, Principle Investigator, Brown University
ClinicalTrials.gov 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
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Paclitaxel
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

ClinicalTrials.gov processed this record on April 15, 2014