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Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN)

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN)

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate will be measured.

Outcome Time Frame:

after every 2 cycles of treatment

Safety Issue:


Principal Investigator

Ranee Mehra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center - Medical Oncology


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

December 2009

Related Keywords:

  • Head and Neck Cancer
  • advanced
  • head
  • neck
  • cancer
  • Head and Neck Neoplasms



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111