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A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)

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ClinicalTrials.gov Identifier: NCT00589667
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : March 5, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pemetrexed plus Gemcitabine Phase 2

Detailed Description:

Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be administered per standard guidelines for pemetrexed chemotherapy.

The primary endpoint is the objective radiologic response rate. Radiologic imaging of evaluable disease will take place after every 2 cycles. Patients may remain on study until progression of disease or unacceptable toxicity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)
Study Start Date : September 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
 Drug: Pemetrexed plus Gemcitabine

Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.

Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.

For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist.

Other Names:
  • Alimta
  • LY231514


Outcome Measures
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Primary Outcome Measures :
  1. Overall Objective Response [ Time Frame: 2 years ]

    To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.



Secondary Outcome Measures :
  1. Median Overall Survival [ Time Frame: 2 years ]
    To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.


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

Inclusion Criteria:

  • Patients must have microscopically confirmed epidermoid/squamous cell carcinoma (HNSCC) of the oral cavity, pharynx, larynx, paranasal sinus, or head/neck squamous cell carcinoma unknown primary.
  • Patients must have recurrent or metastatic disease which is not amenable to curative-intent therapy with surgery or radiation.
  • No more than 2 prior cytotoxic therapies in the recurrent or metastatic disease setting are permitted.
  • Patients must be at least 18 years of age.
  • Karnofsky Performance status must be ≥ 70%.
  • Disease must be measurable by RECIST criteria.
  • At least 4 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
  • Prior radiation therapy to ≤ 25% of bone marrow is allowed. Prior radiation to the whole pelvis and/or brain is not allowed.
  • Adequate organ function
  • Patients of childbearing potential must have a negative test for pregnancy at time of enrollment based on a urine or serum pregnancy test. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  • Patient must reside in geographic proximity to MSKCC for adequate follow-up during treatment, per investigator discretion.
  • Patients must sign an informed consent document.

Exclusion Criteria:

  • Previous exposure to pemetrexed (Alimta) or gemcitabine (Gemzar).
  • Pregnancy or breast-feeding.
  • Serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • History of any brain metastases.
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
  • Patients will be excluded if they will be unable to hold use of nonsteroidal antiinflammatory agents (NSAIDS) with short elimination half lives
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00589667


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: David G Pfister, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00589667    
Other Study ID Numbers: 06-087
First Posted: January 10, 2008    Key Record Dates
Results First Posted: March 5, 2014
Last Update Posted: April 2, 2014
Last Verified: March 2014
Keywords provided by Memorial Sloan Kettering Cancer Center:
Head and Neck Cancer
GEMCITABINE
PEMETREXED
ALTIMA
epidermoid/squamous cell
 carcinoma
pharynx
larynx
paranasal sinus
head/neck squamous cell carcinoma
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
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