Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In

Status Completed

Clinical Trial 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.

Clinical Trial Description

Published data demonstrate equal efficacy and improved quality of life when platinum and a taxane were compared with platinum and 5-Fluorouracil [31]. Additionally, weekly cisplatin regimens (30-40 mg/m2) with radiotherapy appear to be equally efficacious and better tolerated than standard high-dose cisplatin (100 mg/ m2) regimens with radiation therapy for locally advanced SCCHN [32] The investigators will thus attempt to reduce toxicity from induction chemotherapy with the use of docetaxel/cisplatin (or carboplatin) (TP) in place of our previously used standard regimen of cisplatin and 5-fluorouracil (PF) and administer weekly cisplatin (or carboplatin) with radiation for those patients who are responders to induction therapy. Finally, Phase I/II testing of the small molecule inhibitor, AT-101, has recently been completed, and suggests activity in solid tumors when combined with cytotoxic agents. Since the investigators have achieved such high survival rates with our treatment selection approach in laryngeal cancer, our ultimate goal is to reduce the rate of salvage laryngectomy which should improve quality of life. The investigators hypothesize that specific inhibition of Bcl-2/Bcl-xL function can increase response rates to neoadjuvant chemotherapy and decrease the need for salvage laryngectomy. Hence, the investigators propose this study: the treatment of patients with advanced SCC of the larynx with one cycle of platinum plus docetaxel with AT-101, followed by chemoradiotherapy for those responding to this induction regimen and reserving total laryngectomy for those who are non-responders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01633541
Study type	Interventional
Source	University of Michigan Rogel Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	March 2012
Completion date	November 6, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01089803` - Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer	N/A
Completed	`NCT00026975` - Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients	Phase 2
Completed	`NCT01435252` - A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab	Phase 2
Recruiting	`NCT04174950` - Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients	N/A
Recruiting	`NCT05857202` - Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer
Recruiting	`NCT06077643` - Workshops and Exchange Groups for Laryngectomized Patients
Not yet recruiting	`NCT06137378` - European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]	Phase 2
Active, not recruiting	`NCT02586207` - Pembrolizumab in Combination With CRT for LA-SCCHN	Phase 1
Recruiting	`NCT02012699` - Integrated Cancer Repository for Cancer Research
Recruiting	`NCT05375266` - Immune Biomarker Study for Head and Neck Cancer
Completed	`NCT03134976` - Wound Complications in Head and Neck Surgery
Recruiting	`NCT04650919` - Aortic Laryngeal Rehabilitation Graft	N/A
Recruiting	`NCT05830240` - A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer	Early Phase 1
Terminated	`NCT02437513` - NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration	N/A
Completed	`NCT01332682` - Resistance Training and Physical Functioning in Head and Neck Cancer Patients	Phase 1
Terminated	`NCT00011492` - Patient Evaluation for Head and Neck Surgery Branch Studies
Recruiting	`NCT05349487` - SpeakFree Heat and Moisture Exchanger (HME)	N/A
Completed	`NCT00467948` - Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients	Phase 3
Recruiting	`NCT06024980` - Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy	N/A
Recruiting	`NCT03747783` - Nomograms to Precisely Predict Conditional Risk of Survival for Patients With Laryngeal Cancer

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms