Phase I Study of Concomitant Pemetrexed and Cisplatin Plus External Beam Radiation Therapy in Patients with Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Carcinomas

Emad Elquza; Hani M Babiker; Krisha J Howell; Andrew I Kovoor; Thomas David Brown; Hitendra Patel; Steven A Malangone; Mitesh J Borad; Tomislav Dragovich

doi:10.3109/07357907.2015.1108426

Phase I Study of Concomitant Pemetrexed and Cisplatin Plus External Beam Radiation Therapy in Patients with Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Carcinomas

Cancer Invest. 2016;34(2):57-63. doi: 10.3109/07357907.2015.1108426. Epub 2016 Jan 25.

Authors

Emad Elquza¹, Hani M Babiker¹, Krisha J Howell², Andrew I Kovoor³, Thomas David Brown⁴, Hitendra Patel¹, Steven A Malangone¹, Mitesh J Borad⁵, Tomislav Dragovich⁶

Affiliations

¹ a Division of Hematology and Oncology, University of Arizona Cancer Center , Tucson , AZ , USA.
² b Department of Radiation Oncology , University of Arizona , Tucson , AZ , USA.
³ c Department of Medicine , University of Arizona , Tucson , AZ , USA.
⁴ d Swedish Cancer Institute , Seattle , WA , USA.
⁵ e Division of Hematology and Oncology, Mayo Clinic , Scottsdale , AZ , USA.
⁶ f Banner MD Anderson Cancer Center , Gilbert , AZ , USA.

PMID: 26810581
DOI: 10.3109/07357907.2015.1108426

Abstract

Purpose: To establish the maximum tolerated dose (MTD) and safety profile of bi-weekly Pemetrexed (PEM) when combined with weekly cisplatin (CDDP) and standard dose external beam radiation (EBRT) in patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) carcinomas.

Methods: We conducted an open label, single institution, phase I dose escalation study designed to evaluate up to 15-35 patients with advanced or metastatic esophageal and GEJ carcinomas.

Results: 10 patients were treated with bi-weekly PEM, weekly CDDP, and EBRT. The MTD of bi-weekly PEM was determined to be 500 mg/m(2).

Trial registration: ClinicalTrials.gov NCT00701857.

Keywords: Pemetrexed; cisplatin; gastroesophageal carcinoma; radiation.

Publication types

Clinical Trial, Phase I
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Arizona
Carcinoma / mortality
Carcinoma / secondary
Carcinoma / therapy*
Chemoradiotherapy / adverse effects
Chemoradiotherapy / methods*
Chemoradiotherapy / mortality
Cisplatin / administration & dosage*
Cisplatin / adverse effects
Disease Progression
Drug Administration Schedule
Esophageal Neoplasms / mortality
Esophageal Neoplasms / pathology
Esophageal Neoplasms / therapy*
Esophagectomy
Esophagogastric Junction / drug effects*
Esophagogastric Junction / pathology
Esophagogastric Junction / radiation effects*
Female
Humans
Male
Maximum Tolerated Dose
Middle Aged
Pemetrexed / administration & dosage*
Pemetrexed / adverse effects
Radiotherapy Dosage
Remission Induction
Time Factors
Treatment Outcome

Substances

Pemetrexed
Cisplatin

Associated data

ClinicalTrials.gov/NCT00701857