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Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
Pemetrexed
radiation therapy
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage III esophageal cancer, stage IV esophageal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of esophageal or gastroesophageal junction carcinoma

    • Stage III or IV disease
  • Treatment with chemoradiotherapy is considered appropriate
  • Measurable or evaluable disease

  • Clinically significant pleural or pericardial effusions or ascites allowed provided they were drained prior to study entry

    • No pleurodesis within the past 2 weeks
  • Controlled brain metastasis allowed provided patient is clinically stable with no signs of progression by MRI or CT scan of the brain ≥ 60 days after completion of treatment AND is asymptomatic and does not require steroids

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 2,500/mm^3
  • ANC ≥ 1,500/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin normal

  • Alkaline phosphatase AND AST and ALT meeting the following criteria:

    • Alkaline phosphatase normal AND AST or ALT ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastases)
    • Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • Able to take folic acid, vitamin B_12, or corticosteroids
  • No known severe hypersensitivity reaction to study drugs
  • No uncontrolled serious active infection
  • No pre-existing peripheral neuropathy > grade 1

  • No significant cardiac disease, including any of the following:

    • Uncontrolled high blood pressure
    • Unstable angina
    • Congestive heart failure within the past 6 months
    • Left ventricular ejection fraction below the lower limit of normal
    • Myocardial infarction within the past year
    • Serious cardiac arrhythmias requiring medication

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic therapy regimens
  • No prior radiotherapy to gastric/esophageal fields
  • No aspirin or other NSAID before and after pemetrexed disodium administration
  • No concurrent colony-stimulating factors (CSF) to maintain WBC and ANC eligibility values

Sites / Locations

  • University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed, Cisplatin, Radiation Therapy

Arm Description

Concomitant Pemetrexed and CDDP Plus Radiation Therapy

Outcomes

Primary Outcome Measures

The maximum tolerated dose (MTD) of pemetrexed

Secondary Outcome Measures

Toxicity profile
Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria

Full Information

First Posted
June 18, 2008
Last Updated
April 19, 2016
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00701857
Brief Title
Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Official Title
Phase I Study of Concomitant Pemetrexed and CDDP Plus Radiation Therapy in Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal (GEJ) Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with cisplatin and radiation therapy in treating patients with stage III or stage IV esophageal cancer or gastroesophageal junction cancer.
Detailed Description
OBJECTIVES: Primary To establish the maximum tolerated dose of pemetrexed disodium in combination with cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or gastroesophageal junction carcinoma. Secondary To specifically characterize the toxicity profile of this regimen. To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by standard response criteria (RECIST criteria), in patients with measurable disease. OUTLINE: This is a dose-escalation study of pemetrexed disodium. Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and cisplatin IV over 10 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external beam radiotherapy once daily, 5 days a week, for up to 6 weeks. After completion of study therapy, patients are followed for 30 days and then every 3 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage III esophageal cancer, stage IV esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemetrexed, Cisplatin, Radiation Therapy
Arm Type
Experimental
Arm Description
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
Standard weekly dose
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Pemetrexed disodium
Intervention Description
Biweekly pemetrexed dose escalation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
RT
Intervention Description
Weekly standard dose radiation therapy
Primary Outcome Measure Information:
Title
The maximum tolerated dose (MTD) of pemetrexed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
12 months
Title
Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of esophageal or gastroesophageal junction carcinoma Stage III or IV disease Treatment with chemoradiotherapy is considered appropriate Measurable or evaluable disease Clinically significant pleural or pericardial effusions or ascites allowed provided they were drained prior to study entry No pleurodesis within the past 2 weeks Controlled brain metastasis allowed provided patient is clinically stable with no signs of progression by MRI or CT scan of the brain ≥ 60 days after completion of treatment AND is asymptomatic and does not require steroids PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks WBC ≥ 2,500/mm^3 ANC ≥ 1,500/mm^3 Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000/mm^3 Total bilirubin normal Alkaline phosphatase AND AST and ALT meeting the following criteria: Alkaline phosphatase normal AND AST or ALT ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastases) Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal Creatinine clearance ≥ 45 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study therapy Able to take folic acid, vitamin B_12, or corticosteroids No known severe hypersensitivity reaction to study drugs No uncontrolled serious active infection No pre-existing peripheral neuropathy > grade 1 No significant cardiac disease, including any of the following: Uncontrolled high blood pressure Unstable angina Congestive heart failure within the past 6 months Left ventricular ejection fraction below the lower limit of normal Myocardial infarction within the past year Serious cardiac arrhythmias requiring medication PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior systemic therapy regimens No prior radiotherapy to gastric/esophageal fields No aspirin or other NSAID before and after pemetrexed disodium administration No concurrent colony-stimulating factors (CSF) to maintain WBC and ANC eligibility values
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Elquza, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26810581
Citation
Elquza E, Babiker HM, Howell KJ, Kovoor AI, Brown TD, Patel H, Malangone SA, Borad MJ, Dragovich T. 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.
Results Reference
derived

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Pemetrexed, Cisplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer

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