Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00507858 · ClinicalTrials.gov registry record · Phase 1

Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer

A Phase 1 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT00507858 is a Phase 1 study of Head and Neck Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00507858, a Phase 1 study of Head and Neck Cancer, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

Primary Objective: * To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone) Secondary Objectives: * To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia \> 7 days duration, neutropenic fever, grade 4 thrombocytopenia, or any grade 3 or 4 non-hematologic toxicity excluding nausea/vomiting and excluding grade 3 transaminase toxicity. * To determine objective response rate, as defined as complete response (CR) or partial response (PR), confirmed by 2 CT scans at least 6 weeks apart in patients treated with pemetrexed as a single agent with advanced squamous cell carcinoma of the head and neck.

Conditions Studied

Head and Neck Cancer

Interventions

  • DRUG Pemetrexed
  • DRUG Dexamethasone

Study Locations (1)

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2005-09
Est. Completion 2011-09
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00507858

The ClinicalTrials.gov registry entry for NCT00507858 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pemetrexed is the first listed.

NCT00507858 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00507858 about?

NCT00507858 is a clinical study titled "Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell Cancer". Primary Objective: * To determine the maximum tolerated doses (MTDs) of pemetrexed when given with dexamethasone. (Please note: One of the three treatment groups will not receive dexamethasone) Secondary Objectives: * To assess dose limiting toxicity (DLT), which is defined as grade 4 neutropenia...

What is the current status of trial NCT00507858?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2005-09. Estimated completion is 2011-09.

What conditions does trial NCT00507858 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT00507858?

The interventions under investigation include: Pemetrexed (DRUG), Dexamethasone (DRUG).

Who is sponsoring clinical trial NCT00507858?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00507858 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Head and Neck Cancer

All registered trials for this condition

Texas

All trials with a study site in Texas

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.