Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

This study has been terminated.
(stopped for lack of efficacy)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00394147
First received: October 27, 2006
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: pemetrexed
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN)

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Response rate will be measured. [ Time Frame: after every 2 cycles of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives will be to measure the time to progression overall survival. [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: at least weekly ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394147

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

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00394147     History of Changes
Other Study ID Numbers: FER-HN-003
Study First Received: October 27, 2006
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
advanced
head
neck
cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on April 20, 2014