Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer
The purpose of this study is to investigate a new agent Axitinib in the treatment of head and neck cancer.
This is a new drug that is given as a pill twice a day to treat cancer. This is one of the new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells are known to carry this protein on their surface. Research in animals and in patients with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth. The investigators do not know, however, whether Axitinib is effective in head and neck cancer. This research study is being conducted to learn if Axitinib works in head and neck cancer, and also to learn to predict who would benefit from it. Four blood draws will be done to check special blood tests while the subjects are treated with Axitinib. These will be drawn at the same time as your routine labs, and there will not be additional sticks needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the cancer cells are responding to treatment. By testing these blood and tissue samples, the researchers will look at special tests (protein molecules) to try to determine what kind of head and neck patients would best respond to this drug. This is an open-label study, meaning that all subjects are on the active drug and there is no placebo (sugar pill).
Head and Neck Squamous Cell Carcinoma
Drug: Axitinib (AG-013736)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Evaluating Axitinib (AG-013736) In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer|
- Percentage of Patients Alive and Free of Progression at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.
- Number of Participants Who Achieved Complete Response, Partial Response or Stable Disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine the disease control rate (complete response+partial response+stable disease), in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.
Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) will be used.
Complete Response is defined as the disappearance of all tumor for a period of one month.
Partial Response is defined as a 30% or more decrease in the sum of the longest diameters (LD) of all measured lesions without any evidence of progression of any lesion or the appearance of any new lesion for a period of one month.
Stable Disease is defined as any change in measurable disease which is less than the criteria for partial remission or progression without any evidence of new lesions and persisting for at least 2 evaluations or 2 months.
- Number of Patients That Experienced Grade 3 or 4 Toxicities [ Time Frame: 28 Days Post Treatment ] [ Designated as safety issue: Yes ]The number of patients who develop these while on treatment and for 28 days after cessation of axitinib, and graded in severity per CTCAE v. 3.0 and as described in the protocol. According to the CTCAE v. 3.0, grade 3 toxicities are severe and grade 4 toxicities are life-threatening or disabling.
- Median Progression-Free Survival (PFS)Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]To evaluate PFS time in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) treated with Axitinib.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Axitinib (AG-013736)
A prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma who have received no more than two prior lines of systemic therapy for recurrent or metastatic head and neck cancer.
Drug: Axitinib (AG-013736)
The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression (defined per RECIST [Response Evaluation Criteria In Solid Tumors] criteria, or obvious progression on clinical or laryngoscopic/endoscopic exam) or intolerable toxicity (defined as below). During treatment on this protocol, all patients will be evaluated for safety. Correlative biomarker analysis will also be conducted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469546
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Francis P Worden, MD||University of Michigan Cancer Center|