Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: pemetrexed; Drug: gemcitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pemetrexed and gemcitabine; pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle	Drug: pemetrexed; pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle; Other Names: Alimta; Drug: gemcitabine; gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle; Other Names: Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		1 year
Time to Progression	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	1 year

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Ranee Mehra, MD, Fox Chase Cancer Center - Medical Oncology

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: October 27, 2006
• First Submitted That Met QC Criteria: October 27, 2006
• First Posted (ESTIMATE): October 31, 2006

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cancer; advanced; head; neck
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Folic Acid Antagonists; Gemcitabine; Pemetrexed
• Other Study ID Numbers: FER-HN-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO