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Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

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. Identifier: NCT00394147
Recruitment Status : Terminated (stopped for lack of efficacy)
First Posted : October 31, 2006
Last Update Posted : March 2, 2012
Eli Lilly and Company
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:
The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: pemetrexed Drug: gemcitabine Phase 2

Detailed Description:

This research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (SCCHN). Pemetrexed and gemcitabine have helped fight against SCCHN when each was given by itself. This study is different from others because it tests these two drugs together, which has not been tried before in patients with SCCHN. We will see how well these drugs can work to help to control or shrink your cancer.

We also want to find out what effects (good and bad) gemcitabine and pemetrexed have on you and your head and neck cancer. We do not know if these drugs will help you. Your cancer might get better or it might get worse. It might not have any effect on your condition. We can use what we learn from this research study to help other people with the same cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN)
Study Start Date : October 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: pemetrexed
    pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
    Other Name: Alimta
  • Drug: gemcitabine
    gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
    Other Name: Gemzar

Primary Outcome Measures :
  1. Response rate will be measured. [ Time Frame: after every 2 cycles of treatment ]

Secondary Outcome Measures :
  1. Secondary objectives will be to measure the time to progression overall survival. [ Time Frame: after every 2 cycles ]
  2. Safety [ Time Frame: at least weekly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of squamous cell cancer of the head and neck - unresectable or metastatic. Must have measurable disease by RECIST.
  • Karnofsky performance status greater than or equal to 60%
  • Up to one prior systemic chemotherapy, immunotherapy allowed in the advanced or metastatic setting. This does not include prior chemotherapy, immunotherapy used with radiotherapy (ie concurrent with radiation therapy or as and induction regimen pror to definitive radiation therapy).
  • At least 4 weeks from prior radiation or chemotherapy, must have recovered from all acute effects of treatment.
  • Adequate organ and marrow function
  • Negative pregnancy test. Agree to use birth control during and for 3 months after last dose of study drug.
  • At least 18 years of age.
  • Sign an informed consent and HIPAA consent.
  • Must be able to take and absorb enteral medication.

Exclusion Criteria:

  • Serious concomitant systemic disorder that would compromise safety or ability to complete study.
  • Prior treatment with gemcitabine or pemetrexed within the previous year, unless used concurrently with radiation therapy.
  • Pregnancy or breastfeeding.
  • Symptomatic or uncontrolled brain mets. If treated, must be off steroids for at least 2 weeks.
  • Inability or unwilling to take folic acid, vitamin B12, or dexamethasone.
  • Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
  • Inability to interrupt and NSAID or salicylate with a long half-life (piroxicam or nabumetone) for a 5 day period.
  • Presence of clinically relevant third space fluid that cannot be controlled by drainage or other procedure prior to study entry.
  • Active, concurrent, invasive malignancy requiring ongoing treatment.
  • Corticosteroids impermissible unless for adrenal failure, septic shock or as temporizing measure for symptomatic pain, breathing, or rash.

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 identifier (NCT number): NCT00394147

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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Eli Lilly and Company
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Principal Investigator: Ranee Mehra, MD Fox Chase Cancer Center - Medical Oncology

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Responsible Party: Fox Chase Cancer Center Identifier: NCT00394147     History of Changes
Other Study ID Numbers: FER-HN-003
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012
Keywords provided by Fox Chase Cancer Center:
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors