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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: Completed Phase 1 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD for pemetrexed within each schedule of dexamethasone is defined as the highest dose level in which less than 2 instances of dose limiting toxicities (DLT) observed out of 6 treated participants.
Conditions Studied
Interventions
- DRUG Pemetrexed
- DRUG Dexamethasone
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT00507858 record still lists
NCT00507858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Where NCT00507858's enrollment target sits among peer trials
36 163rd of 250 higher than 87 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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