NCT00394147

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
12.7 years until next milestone

Results Posted

Study results publicly available

August 5, 2022

Completed
Last Updated

August 5, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

October 27, 2006

Results QC Date

January 26, 2022

Last Update Submit

July 12, 2022

Conditions

Head and Neck Cancer

Keywords

advancedheadneckcancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time to Progression

    1 year

  • Overall Survival

    1 year

Study Arms (1)

Pemetrexed and gemcitabine

EXPERIMENTAL

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

Drug: pemetrexedDrug: gemcitabine

Interventions

pemetrexedDRUG

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

Also known as: Alimta
Pemetrexed and gemcitabine
gemcitabineDRUG

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

Also known as: Gemzar
Pemetrexed and gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Interventions

PemetrexedGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Ranee Mehra
Organization
University of Maryland
rmehra@umd.edu
410-328-7904

Study Officials

  • Ranee Mehra, MD

    Fox Chase Cancer Center - Medical Oncology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2006

First Posted

October 31, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2008

Study Completion

December 1, 2009

Last Updated

August 5, 2022

Results First Posted

August 5, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)