Tongue Cancer Clinical Trial
Official title:
A Randomized Phase II Study of BMS-247550 (NSC #710428) Given Daily x 5 Days Every 3 Weeks or Weekly in Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. To determine the response rate and toxicity of BMS-247550 given in two dosing schedules
in taxane-naïve and taxane-exposed patients.
II. To provide information about the response rate and toxicity of BMS-247550 given in two
dosing schedules.
SECONDARY OBJECTIVES:
I. To measure surviving expression and correlate with the therapeutic responsiveness to
BMS-247550.
II. To determine the changes in tumor vascular density and endothelial cell apoptosis in
response to therapy and the correlation of these changes to outcome.
OUTLINE: This is a randomized study. Patients are stratified according to prior taxane
therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2
treatment arms.
Arm I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days
in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
In both arms, patients achieving complete response (CR) receive 2 additional courses past CR
if a minimum of 6 courses have been administered.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01469429 -
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04041141 -
Oral Stent Device for Radiation Treatments of Oral Cancers
|
||
| Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00096512 -
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT01816841 -
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
|
N/A | |
| Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
| Completed |
NCT04059861 -
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin
|
N/A | |
| Recruiting |
NCT01854021 -
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
|
N/A | |
| Withdrawn |
NCT01674374 -
Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
|
Phase 2 | |
| Completed |
NCT01816984 -
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01528137 -
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT04337853 -
Radiotherapy of Tongue Cancer Using an Intraoral Stent
|
Phase 1 | |
| Completed |
NCT01806675 -
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01847326 -
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
|
Phase 1 | |
| Terminated |
NCT02177838 -
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
|
N/A | |
| Completed |
NCT00114283 -
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT04126226 -
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
|
N/A | |
| Completed |
NCT00293462 -
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
|
Phase 3 |