A RANDOMIZED PHASE II STUDY OF CONCURRENT INTENSITY MODULATED RADIATION THERAPY (IMRT), PACLITAXEL AND PAZOPANIB (NSC 737754)/PLACEBO, FOR THE TREATMENT OF ANAPLASTIC THYROID CANCER
PRIMARY OBJECTIVES:
I. To evaluate the safety of IMRT, paclitaxel, and pazopanib. (Run-in component) II. To
evaluate and compare overall survival at 1 year from study registration. (Phase II
component)
SECONDARY OBJECTIVES:
I. To evaluate local-regional control at 6 and 12 months. (Phase II component) II. To
evaluate the rate of grade 4 (Common Terminology Criteria for Adverse Events [CTCAE], v.
4.0) hemorrhage, grade 4 febrile neutropenia, or any grade 5 adverse event assessed to be
definitely, probably, or possibly related to the induction or concurrent treatment
components of the protocol regimen. (Phase II component) III. To evaluate the rates of other
adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly related to
the induction or concurrent treatment components of the protocol regimen. (Phase II
component) IV. To evaluate the rate of treatment discontinuation due to toxicity during the
induction or concurrent treatment components of the protocol regimen. (Phase II component)
V. To evaluate the rate of grade 4 (CTCAE, v. 4.0) hemorrhage or any grade 5 adverse event
assessed to be definitely, probably, or possibly related to adjuvant paclitaxel or
pazopanib/placebo after concurrent treatment. (Phase II component) VI. To evaluate the rates
of other adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly
related to adjuvant paclitaxel or pazopanib/placebo after concurrent treatment. (Phase II
component) VII. To evaluate response (as per Response Evaluation Criteria in Solid Tumors
[RECIST]) of the primary site following the treatment component in subjects with measurable
disease prior to chemoradiation. (Phase II component)
OUTLINE:
RUN-IN COMPONENT: Patients receive paclitaxel intravenously (IV) over 1 hour once weekly and
oral pazopanib hydrochloride once daily for 2-3 weeks. Patients then receive concurrent
paclitaxel IV over 1 hour once weekly and oral pazopanib hydrochloride once daily for 6
weeks and intensity-modulated radiotherapy (IMRT) 5 days per week for 6.5 weeks (total of 66
Gy in 33 fractions). Beginning 25-31 days after the completion of IMRT, patients receive
paclitaxel IV over 1 hour once weekly and oral pazopanib hydrochloride once daily. Treatment
repeats every 3 weeks for 4 courses (for patients with no measurable disease) or continues
in the absence of disease progression or unacceptable toxicity (for patients with measurable
disease).
RANDOMIZED PHASE II COMPONENT: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 1 hour once weekly and oral pazopanib
hydrochloride once daily for 2-3 weeks. Patients then receive concurrent paclitaxel IV over
1 hour once weekly and oral pazopanib hydrochloride once daily for 6 weeks and IMRT 5 days
per week for 6.5 weeks (total of 66 Gy in 33 fractions). Beginning 25-31 days after the
completion of IMRT, patients receive paclitaxel IV over 1 hour once weekly and oral
pazopanib hydrochloride once daily. Treatment repeats every 3 weeks for 4 courses (for
patients with no measurable disease) or continues in the absence of disease progression or
unacceptable toxicity (for patients with measurable disease).
ARM II: Patients receive paclitaxel IV over 1 hour once weekly and oral placebo once daily
for 2-3 weeks. Patients then receive concurrent paclitaxel IV over 1 hour once weekly and
oral placebo once daily for 6 weeks and IMRT 5 days per week for 6.5 weeks (total of 66 Gy
in 33 fractions). Beginning 25-31 days after the completion of IMRT, patients receive
paclitaxel IV over 1 hour once weekly and oral placebo once daily. Treatment repeats every 3
weeks for 4 courses (for patients with no measurable disease) or continues in the absence of
disease progression or unacceptable toxicity (for patients with measurable disease).
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 1 year, and then annually thereafter.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Discontinuation of treatment due to toxicity, Grade 4 (CTCAE v. 4.0) hemorrhage, grade 4 febrile neutropenia, or any grade 5 adverse event that is assessed to be definitely, probably, or possibly related to the induction or concurrent treatment
Up to 4 years
Yes
Eric Sherman
Principal Investigator
Radiation Therapy Oncology Group
United States: Food and Drug Administration
NCI-2011-02614
NCT01236547
October 2010
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Summa Barberton Hospital | Barberton, Ohio 44203 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Intermountain Medical Center | Murray, Utah 84157 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah 84106 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
UCSF-Mount Zion | San Francisco, California 94115 |
Sentara Hospitals | Norfolk, Virginia 23507 |
The James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Sentara Virginia Beach General Hospital | Virginia Beach, Virginia 23454 |