Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck
This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when
administered with erlotinib in patients with recurrent or metastatic head and neck cancer.
II. Determine the objective response rate and stable disease/absence of early progression in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized, multicenter
study.
Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on
days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Phase II: Course 1 is 28 days in length. All subsequent courses are 21 days.
Course 1: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on
days 1-28.
Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on
days 1-28.
All subsequent courses: All patients receive bevacizumab as in arm II and oral erlotinib on
days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
;
| 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 | |
| Completed |
NCT01155609 -
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
|
N/A | |
| Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT01044433 -
Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
| Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00098631 -
Lapatinib in Treating Patients With Recurrent and/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 |
NCT00055770 -
Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01249443 -
Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection
|
Phase 1 | |
| Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00033618 -
Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
| 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 | |
| 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 | |
| Terminated |
NCT01682031 -
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
|
Phase 2 | |
| Completed |
NCT00492089 -
Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00410826 -
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00084682 -
Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 |