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NCT01064921 · ClinicalTrials.gov registry record · Phase 1

Ph I Vorinostat in the Treatment of Advanced Staged Oropharyngeal Squamous Cell Carcinoma

A Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
1
Study location

NCT01064921: Completed Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, sponsored by Ohio State University Comprehensive Cancer Center.

NCT01064921 is a Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 154-participant average among 4 other Stage III Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01064921, a Phase 1 study of Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IV Squamous Cell Carcinoma of the Oropharynx, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

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

Study Summary

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving vorinostat together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with cisplatin and radiation therapy in treating patients with stage III or stage IVa squamous cell cancer of the oropharynx which is either unresectable or borderline resectable.

Interventions

  • DRUG cisplatin
  • DRUG vorinostat
  • RADIATION radiation therapy
  • PROCEDURE Correlative Studies

Study Locations (1)

Ohio

  • The Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-01-19
Est. Completion 2017-11-08
Phase Phase 1

What the finished NCT01064921 record still lists

NCT01064921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 154-participant average among 4 other Stage III Squamous Cell Carcinoma of the Oropharynx trials with a reported enrollment target (82% lower).

The record links to 2 conditions, with Stage III Squamous Cell Carcinoma of the Oropharynx appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.

NCT01064921 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT01064921 about?

NCT01064921 is a clinical study titled "Ph I Vorinostat in the Treatment of Advanced Staged Oropharyngeal Squamous Cell Carcinoma". RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy u...

What is the current status of trial NCT01064921?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-01-19. Estimated completion is 2017-11-08.

What conditions does trial NCT01064921 study?

This clinical trial studies the following conditions: Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx.

What interventions are being tested in trial NCT01064921?

The interventions under investigation include: cisplatin (DRUG), vorinostat (DRUG), radiation therapy (RADIATION), Correlative Studies (PROCEDURE).

Who is sponsoring clinical trial NCT01064921?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01064921 being conducted?

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

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Source: ClinicalTrials.gov NCT01064921, the US trial registry maintained by the National Library of Medicine. NCT01064921 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.