Status:
TERMINATED
Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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 agai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00394147
Start Date
October 1 2006
End Date
December 1 2009
Last Update
August 5 2022
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111