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NCT02035527 · ClinicalTrials.gov registry record · Phase 1
Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study of Recurrent Salivary Gland Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT02035527: Completed Phase 1 study of Recurrent Salivary Gland Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
NCT02035527 is a Phase 1 study of Recurrent Salivary Gland Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02035527, a Phase 1 study of Recurrent Salivary Gland Cancer and Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.
Primary Outcome
A DLT will be considered a grade 3 non-hematologic toxicity or grade 4 hematologic toxicity that are probably or definitely related to treatment and result in treatment delay of more than 14 days.
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG docetaxel
- DRUG sorafenib tosylate
- OTHER Correlative Studies
Study Locations (1)
Ohio
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-04-14 |
| Est. Completion | 2017-04-20 |
| Phase | Phase 1 |
What the finished NCT02035527 record still lists
NCT02035527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Recurrent Salivary Gland Cancer appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.
NCT02035527 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02035527 about?
NCT02035527 is a clinical study titled "Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as ci...
What is the current status of trial NCT02035527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-04-14. Estimated completion is 2017-04-20.
What conditions does trial NCT02035527 study?
This clinical trial studies the following conditions: Recurrent Salivary Gland Cancer, Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity.
What interventions are being tested in trial NCT02035527?
The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), sorafenib tosylate (DRUG), Correlative Studies (OTHER).
Who is sponsoring clinical trial NCT02035527?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02035527 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02035527's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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