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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 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.

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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 Registry Record Tells You About NCT01064921

The ClinicalTrials.gov registry entry for NCT01064921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, 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 listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.