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NCT00076310 · ClinicalTrials.gov registry record · Phase 2
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
A Phase 2 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00076310: Active Phase 2 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00076310 is a Phase 2 study of Head and Neck Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00076310, a Phase 2 study of Head and Neck Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG OSI-774
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-01-28 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT00076310 still lists
NCT00076310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT00076310 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00076310 about?
NCT00076310 is a clinical study titled "OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer". The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
What is the current status of trial NCT00076310?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-01-28. Estimated completion is 2026-06-30.
What conditions does trial NCT00076310 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00076310?
The interventions under investigation include: Docetaxel (DRUG), Cisplatin (DRUG), OSI-774 (DRUG).
Who is sponsoring clinical trial NCT00076310?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00076310 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 NCT00076310's enrollment target sits among peer trials
50 132nd of 250 higher than 117 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.
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