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Head and Neck CancerPhase 1NCT00291707

Trial of Cetuximab and Pemetrexed With Radiation in Head and Neck Cancer

A Phase 1 study testing Cetuximab, Pemetrexed and radiation therapy in people with Head and Neck Cancer, run by University of Pittsburgh 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

The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab, Pemetrexed and radiation therapy
How many people
40 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jan 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed head and neck malignancy
  • All subjects requiring radiotherapy to the head and neck for a poor-prognosis malignancy will be eligible.
  • Two cohorts of subjects: no prior history of head and neck radiation, i.e. non-irradiated and prior history of head and neck radiation, i.e. previously irradiated.
  • Subjects with recurrent head and neck cancer with no clinically measurable distant disease as well as those subjects in whom distant disease was of low volume and local and regional palliation is clinically warranted will be eligible.
  • Subjects without prior treatment should have stage IV disease (see AJCC staging system in Appendix 2, Protocol) or have an expected long-term survival of less than 10%.
  • No prior treatment with systemic anti-EGFR inhibitors or Pemetrexed. Any number of prior systemic therapies is allowed.
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  • Measurable or evaluable disease.
  • ECOG performance status 0-2 .
  • Age ³ 18 years.
  • Subjects must have fully recovered from the effects of any prior surgery, chemotherapy, or radiation therapy. A minimum time period of 4 weeks should elapse between the completion of prior chemotherapy and enrollment in the study.
  • ANC ³ 1500/µl, platelet count ³ 100,000/µl. Hemoglobin should be >8 g/dL.
  • Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula: Calculated Creatinine Clearance = (140-age) X actual body wt.(kg) 72 X serum creatinine Multiply this number by 0.85 if the subject is female
  • Total bilirubin within normal limits and AST/ALT less than 3 times the upper limit of normal (less than 5 times the upper limit of normal in the presence of liver metastases).
  • Informed consent must be obtained from all subjects prior to beginning therapy. Subjects should have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects should be willing and able to take folic acid and vitamin B12 supplementation and should interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long acting agents such as piroxicam), see section 5.57

Who cannot join

  • Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 3 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
  • May not be receiving any other investigational agents.
  • Pregnant women are excluded from this. Breastfeeding should be discontinued if the mother is treated with chemotherapy. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. Subjects who are women of childbearing potential and sexually active males must be willing to use effective contraception while on study.
  • All WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant .
  • HIV-positive subjects are excluded from the study.
  • Prior grade 3 or 4 infusion or hypersensitivity reaction to a monoclonal antibody.
  • For subjects who have baseline clinically significant pleural or peritoneal effusions before initiation of protocol therapy, consideration should be given to draining the effusion prior to starting therapy due the potential of increased toxicity with Pemetrexed in that setting.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase I Trial of Cetuximab (C225) and Pemetrexed With Concurrent Radiation in Head and Neck Cancer

The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with radiation therapy.

Read the detailed description

The purpose of this Phase I study is to determine the safety and effectiveness of two chemotherapies drugs, Cetuximab and Pemetrexed (Alimta), when given in combination with radiation therapy. Currently Pemetrexed is approved by the Food and Drug Administration (FDA) for two other types of cancer, mesothelioma and lung cancer, but it is considered investigational and is not approved by the FDA for head and neck cancer. Cetuximab is approved by the FDA for the treatment of colorectal cancer; however, it is not yet approved for head and neck cancer.

Pemetrexed is a drug that kills tumor cells by stopping cells from functioning normally. It has been studied in thousands of subjects and has been shown to be effective at killing tumor cells in many cancers, including head and neck cancer. In preclinical studies, Pemetrexed showed such promising activity against a wide range of tumor types including those mentioned above as well as breast, colon, and bladder cancers.

Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of our standard treatment with chemotherapy and radiation. Cetuximab is a type of drug known as a monoclonal antibody. Monoclonal antibodies are used to try to destroy some types of cancer cells while causing little harm to normal cells. They are designed to recognize specific molecules that are on the surface of particular cancer cells. The monoclonal antibody recognizes the protein and locks onto it. This may trigger the body's immune system to attack the cancer cells and can sometimes make the cells destroy themselves. Cetuximab targets the epidermal growth factor receptor (EGFR), an important molecule for the growth of cancer cells. The use of radiation therapy and Cetuximab has also been studied with good results. We will find what effects (good and bad) Cetuximab has on you and your head and neck cancer.

Both Cetuximab and Pemetrexed have been studied intensively to determine their effectiveness.

In this study, we will find what effects (good and bad) Cetuximab and Pemetrexed, with radiation; have on you and on your head and neck cancer. We will find out if the combination of Cetuximab, Pemetrexed and radiation has better results than what we ordinarily expect with radiation and chemotherapy. We will also find out if the side effects are worse than those we usually see. In addition, we will test both blood and tumor tissue and determine what effects Cetuximab has on these specimens. Finally, we will look for "markers," or cancer identifiers, in your tumor cells and blood that may help to predict what the best treatment is for head and neck cancer patients in the future.

Being tested
Cetuximab, Pemetrexed, radiation therapy
Keywords
head, neck, Cetuximab, Pemetrexed
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • CetuximabDrug

    Also called C225, ERBITUX

    The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. The infusion rate of cetuximab must never exceed 5 mL/min.

  • PemetrexedDrug

    Also called ALIMTA

    • Pemetrexed 350-500 mg/m2 IV over 10 minutes (see dose escalation design. Dose will be decreased to 200 mg/m2, if the first dose level of 350 mg/m2 is not tolerable) on days 1 and 22, (and 43 if >6000 cGy to be delivered)

  • radiation therapyProcedure or surgery

    • Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1. Radiation will be given M-F for 6-7 consecutives weeks

What is being measured

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

  1. To evaluate the maximum tolerated doses and dose-limiting toxicities of Pemetrexed and Cetuximab when given concurrently with radiation in poor prognosis subjects with head and neck cancer.

    Measured: 10 years

Secondary outcomes (2)

  1. To evaluate the objective response rate post chemoradiotherapy (in subjects with measurable disease), time to progression, and overall survival with the above therapy.

    Measured: 10 years

  2. To collect tumor tissue from pretreatment biopsies for future biomarker studies and to collect pre- and post-therapy blood samples for future studies, that may include analysis of DNA and RNA extracted from these samples.

    Measured: indefinite

Timeline

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

  1. First posted14 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionMar 2008
  4. Study completionJan 2009

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291707
Sponsor's protocol ID
05-005
Status last verified
May 2013
First submitted
10 Feb 2006
Last updated
6 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetuximab, Pemetrexed and radiation therapy in people with Head and Neck Cancer, run by University of Pittsburgh 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?

The sponsor lists 15 inclusion and 7 exclusion criteria. 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 6 May 2013. 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?

To evaluate the maximum tolerated doses and dose-limiting toxicities of Pemetrexed and Cetuximab when given concurrently with radiation in poor prognosis subjects with head and neck cancer. (time frame: 10 years). 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 NCT00291707.

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 6 May 2013.

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