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Esophageal CancerPhase 1NCT00701857

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

A Phase 1 study testing cisplatin, Pemetrexed and radiation therapy in people with Esophageal Cancer, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Esophageal Cancer
What is being tested?
cisplatin, Pemetrexed and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Feb 2008to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
cisplatin, Pemetrexed, radiation therapy
Keywords
stage III esophageal cancer, stage IV esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    Also called CDDP

    Standard weekly dose

  • PemetrexedDrug

    Also called Pemetrexed disodium

    Biweekly pemetrexed dose escalation

  • radiation therapyRadiation

    Also called RT

    Weekly standard dose radiation therapy

Study groups in NCT00701857
Study groupRoleWhat they receive
Pemetrexed, Cisplatin, Radiation TherapyExperimentalConcomitant Pemetrexed and CDDP Plus Radiation Therapy
Receives: Drug: cisplatin; Drug: Pemetrexed; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum tolerated dose (MTD) of pemetrexed

    Measured: 6 months

Secondary outcomes (2)

  1. Toxicity profile

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2014
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00701857
Sponsor's protocol ID
07-0612-04
Other IDs
P30CA023074, UARIZ-07-0612-04, UARIZ-BIO07067, UARIZ-SRC18084, LILLY-UARIZ-07-0612-04
Status last verified
Apr 2016
First submitted
18 Jun 2008
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26810581

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cisplatin, Pemetrexed and radiation therapy in people with Esophageal Cancer, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) of pemetrexed (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00701857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.

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