Back to results

Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pemetrexed

gemcitabine

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring advanced, head, neck, cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed and gemcitabine

Arm Description

pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Overall Survival

Full Information

NCT ID

NCT00394147

First Posted

October 27, 2006

Last Updated

July 12, 2022

Sponsor

Fox Chase Cancer Center

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00394147

Brief Title

Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

stopped for lack of efficacy

Study Start Date

October 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

advanced, head, neck, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed and gemcitabine

Arm Type

Experimental

Arm Description

pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time to Progression

Description

Time Frame

1 year

Title

Overall Survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranee Mehra, MD

Organizational Affiliation

Fox Chase Cancer Center - Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer

We'll reach out to this number within 24 hrs