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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00522795
Recruitment Status : Completed
First Posted : August 30, 2007
Results First Posted : August 22, 2013
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
University of Maryland Greenebaum Cancer Center
Information provided by (Responsible Party):
howard safran, Brown University

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: PPX with cisplatin and radiation Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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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 Name: Paclitaxel Poliglumex, Cisplatin and radiation


Outcome Measures
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Primary Outcome Measures :
  1. Complete Pathologic Response [ Time Frame: At Surgery approximately 4weeks after last treatment ]
    Per pathology review post surgery


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522795


Locations
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United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
University of Maryland Greenebaum Cancer Center
Investigators
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Principal Investigator: Howard Safran, MD Brown University
More Information
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Responsible Party: howard safran, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00522795    
Other Study ID Numbers: BrUOG-E-215
First Posted: August 30, 2007    Key Record Dates
Results First Posted: August 22, 2013
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by howard safran, Brown University:
Esophageal Cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Paclitaxel
Cisplatin
Paclitaxel poliglumex
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action