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

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

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

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.

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

- Patients will be excluded if they will be unable to hold use of nonsteroidal
antiinflammatory agents (NSAIDS) with short elimination half lives

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective radiologic response rate of pemetrexed + gemcitabine administered q14 days to patients with recurrent or metastatic HNSCC.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David G Pfister, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

July 2010

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • epidermoid/squamous cell
  • carcinoma
  • pharynx
  • larynx
  • paranasal sinus
  • head/neck squamous cell carcinoma
  • Head and Neck Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021