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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701857
First Posted: June 19, 2008
Last Update Posted: April 20, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer Drug: cisplatin Drug: Pemetrexed Radiation: radiation therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • The maximum tolerated dose (MTD) of pemetrexed [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: 12 months ]
  • Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria [ Time Frame: 12 months ]

Enrollment: 10
Study Start Date: February 2008
Study Completion Date: September 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed, Cisplatin, Radiation Therapy
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
Drug: cisplatin
Standard weekly dose
Other Name: CDDP
Drug: Pemetrexed
Biweekly pemetrexed dose escalation
Other Name: Pemetrexed disodium
Radiation: radiation therapy
Weekly standard dose radiation therapy
Other Name: RT

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00701857


Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Emad Elquza, MD University of Arizona
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00701857     History of Changes
Other Study ID Numbers: 07-0612-04
P30CA023074 ( U.S. NIH Grant/Contract )
UARIZ-07-0612-04 ( Other Identifier: University of Arizona )
UARIZ-BIO07067 ( Other Identifier: University of Arizona )
UARIZ-SRC18084 ( Other Identifier: University of Arizona )
LILLY-UARIZ-07-0612-04 ( Other Grant/Funding Number: Eli Lilly )
First Submitted: June 18, 2008
First Posted: June 19, 2008
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by University of Arizona:
stage III esophageal cancer
stage IV 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
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors