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NCT00084682 · ClinicalTrials.gov registry record · Phase 2
Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study of Stage IV Squamous Cell Carcinoma of the Hypopharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT00084682: Completed Phase 2 study of Stage IV Squamous Cell Carcinoma of the Hypopharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, sponsored by National Cancer Institute (NCI).
NCT00084682 is a Phase 2 study of Stage IV Squamous Cell Carcinoma of the Hypopharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00084682, a Phase 2 study of Stage IV Squamous Cell Carcinoma of the Hypopharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.
Primary Outcome
Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as 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. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance
Conditions Studied
Interventions
- DRUG romidepsin
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2005-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT00084682 record still lists
NCT00084682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 4 conditions, with Stage IV Squamous Cell Carcinoma of the Hypopharynx appearing as the primary indexed condition, and to 1 intervention - of which romidepsin is the first listed.
NCT00084682 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT00084682 about?
NCT00084682 is a clinical study titled "Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or d...
What is the current status of trial NCT00084682?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2005-06. Estimated completion is 2012-03.
What conditions does trial NCT00084682 study?
This clinical trial studies the following conditions: Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity.
What interventions are being tested in trial NCT00084682?
The interventions under investigation include: romidepsin (DRUG).
Who is sponsoring clinical trial NCT00084682?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00084682 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00084682's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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