NCT01333696

Brief Summary

The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

April 11, 2011

Last Update Submit

March 2, 2013

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Squamous cell carcinoma of head and neckPemetrexed

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    6 weeks

Secondary Outcomes (2)

  • Median progression-free survival

    1 year

  • Median overall survival

    1 year

Study Arms (1)

Pemetrexed

EXPERIMENTAL

500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity

Drug: Pemetrexed

Interventions

PemetrexedDRUG

Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks

Also known as: Alimta
Pemetrexed

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range: 18-65 years old
  • Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
  • Prior exposure of at least one line of platinum-containing regimen
  • At least one site of measurable disease according to RECIST criteria
  • ECOG performance status 0-1
  • Life expectancy of more than 3 months
  • Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
  • Liver function: total bilirubin, ALT and AST \<1.5×UNL
  • Renal function: Cr\<1.5×UNL, CCR≧45ml/min

You may not qualify if:

  • With curable treatment option
  • Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Significant active infection
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

86 21 64175590pattrick_guo@msn.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 12, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

CN(1)