A Randomized Phase II Study of Androgen Deprivation Versus Combined With IMC-A12 Versus Androgen Deprivation Alone for Patients With New Hormone-Sensitive Metastatic Prostate Cancer
PRIMARY OBJECTIVES:
I. To compare the undetectable PSA rate (PSA < 0.2 ng/mL) after seven cycles (28 weeks) of
protocol treatment between those randomized to a LHRH agonist and bicalutamide and those
randomized to a LHRH agonist, bicalutamide and IMC-A12.
Secondary I. To assess the safety and tolerability of the combination of IMC-A12 with a LHRH
agonist and bicalutamide.
II. To compare the proportion of men who do not achieve a PSA of < 4 ng/mL between the two
groups.
III. To assess the accuracy of the prognostic model of undetectable PSA that was developed
from SWOG-9346 using current trial data from each arm.
IV. To assess serum samples and peripheral blood mononuclear cells (PBMNC) for
pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited
to: IGF-I, free IGF-I, IGF-II, IGFBP2, IGFBP3, Growth Hormone, insulin and C-peptide)
obtained from optional blood specimens both before initiation of androgen deprivation
therapy and twelve weeks after initiation of combined therapy.
V. To determine baseline pre-treatment circulating tumor cell (CTC) quantities and response
to therapy (for those patients with detectable CTC levels ≥ 1) twelve weeks later.
VI. In the same subset of patients where CTC levels are obtained, determine baseline serum
levels of microRNAs to include but not limited to mi-141 both before initiation of androgen
deprivation therapy and twelve weeks after combined therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive androgen deprivation therapy comprising oral bicalutamide once daily
on days 1-28 and either goserelin subcutaneously or leuprolide acetate intramuscularly every
1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15.
Treatment repeats every 28 days for 7 courses in the absence of disease progression or
unacceptable toxicity.
ARM II: Patients receive androgen deprivation therapy comprising bicalutamide and either
goserelin or leuprolide acetate as in arm I.
After completion of study therapy, patients are followed up every 6 months for 2 years and
then annually for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Undetectable PSA rate
7 months
No
Evan Yu
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-02003
NCT01120236
December 2010
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Evergreen Hospital Medical Center | Kirkland, Washington 98033 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Pacific Medical Center-First Hill | Seattle, Washington 98104 |
Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |