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Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer

NCT01633541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-07-20

Study results available
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Summary

To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.

Conditions

  • Laryngeal Cancer

Interventions

DRUG

AT-101

Patients will receive AT-101 40 mg orally two times a day.

DRUG

Docetaxel

Docetaxel (Taxotere) 75 mg/m2

DRUG

Cisplatin

Cisplatin 100 mg/m2

DRUG

Carboplatin

Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Paul Swiecicki, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2021-11-06
Completion
2021-11-06

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633541 on ClinicalTrials.gov