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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Arizona.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00701857
First received: June 18, 2008
Last updated: August 14, 2012
Last verified: August 2012
  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 disodium
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: February 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701857

Locations
United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Emad Elquza, M.D.    520-694-8932      
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Emad Elquza, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00701857     History of Changes
Other Study ID Numbers: 07-0612-04, P30CA023074, UARIZ-07-0612-04, UARIZ-BIO07067, UARIZ-SRC18084, LILLY-UARIZ-07-0612-04
Study First Received: June 18, 2008
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014