UMCC 2010.101 Concomitant Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Bio-selection For Organ Preservation In Patients With Advanced Laryngeal Cancer
18 Years
N/A
Both
Laryngeal Cancer
Trial Information
UMCC 2010.101 Concomitant Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Bio-selection For Organ Preservation In Patients With Advanced Laryngeal Cancer
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.
Inclusion Criteria:
- Patients must have pathologically confirmed, previously untreated, resectable,
squamous cell carcinoma of the larynx
- Disease must be Stage III or IV
- Tumor must be potentially surgically resectable and curable with conventional surgery
and radiation therapy
- Patients must undergo pre-treatment endoscopic tumor staging and CT scanning
- ECOG Performance status 0-1
Exclusion Criteria:
- Prior head and neck malignancy or history of other prior non-head and neck malignancy
within the past 3 years
- Prior head and neck radiation or prior chemotherapy.
- Documented evidence of distant metastases
- Active infection
- Pregnancy or lactation
- Any medical or psychiatric illness which in the opinion of the principal investigator
would compromise the patient's ability to tolerate this treatment
- Patients residing in prison
- Patients with Grade > 2 peripheral neuropathy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Organ preservation rate
Outcome Description:
The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Frank Worden, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
UMCC 2010.101
NCT ID:
NCT01633541
Start Date:
March 2012
Completion Date:
January 2015
Related Keywords:
- Laryngeal Cancer
- Laryngeal Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
