A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
18 Years
70 Years
Both
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Trial Information
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell
Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or
radiation therapy.
- Measurable disease by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Age: 18 years or older
- Adequate hematologic, renal, metabolic, hepatic & thyroid function
Exclusion Criteria:
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- CNS metastases, or nasopharyngeal carcinoma
- History of interstitial lung disease
- History of another primary cancer
- Any co-morbid disease that would increase risk of toxicity
- Active infection requiring systemic treatment
- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
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:
Progression Free Survival (PFS) during the first-line treatment phase
Outcome Description:
Progression Free Survival (PFS) during the first-line treatment phase
Outcome Time Frame:
Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first.
Safety Issue:
Yes
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20050236
NCT ID:
NCT00454779
Start Date:
January 2007
Completion Date:
December 2012
Related Keywords:
- Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
- SCCHNC
- Metastatic
- Recurrent
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Research Site | Mesa, Arizona |
| Research Site | Bentonville, Arkansas |
| Research Site | Anaheim, California |
| Research Site | Boulder, Colorado |
| Research Site | Danbury, Connecticut |
| Research Site | Lewes, Delaware |
| Research Site | Washington, District of Columbia |
| Research Site | Boca Raton, Florida |
| Research Site | Albany, Georgia |
| Research Site | Arlington Heights, Illinois |
| Research Site | Hays, Kansas |
| Research Site | Ashland, Kentucky |
| Research Site | Baltimore, Maryland |
| Research Site | Beverly, Massachusetts |
| Research Site | Battle Kreek, Michigan |
| Research Site | Hattiesburg, Mississippi |
| Research Site | Branson, Missouri |
| Research Site | Billings, Montana |
| Research Site | Grand Island, Nebraska |
| Research Site | Las Vegas, Nevada |
| Research Site | Belleville, New Jersey |
| Research Site | Albany, New York |
| Research Site | Akron, Ohio |
| Research Site | Enid, Oklahoma |
| Research Site | Allentown, Pennsylvania |
| Research Site | Charleston, South Carolina |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abilene, Texas |
| Research Site | Abington, Virginia |
| Research Site | Clarksburg, West Virginia |
| Research Site | Appleton, Wisconsin |
