RANDOMIZED PHASE II STUDY COMPARING TWO SCHEDULES OF TEMOZOLOMIDE IN COMBINATION WITH BAY43-9006 IN PATIENTS WITH ADVANCED MELANOMA
- To measure the progression-free survival of patients with metastatic or unresectable
melanoma with no brain metastasis or no prior treatment with temozolomide (TMZ) treated
with sorafenib tosylate in combination with two different schedules (extended daily
dosing vs standard dosing) of TMZ.
- To measure the progression-free survival of patients with or without brain metastasis
and prior treatment with TMZ treated with sorafenib in combination with extended daily
dosing of TMZ.
- To measure the progression-free survival of patients with brain metastasis and no prior
treatment with TMZ treated with sorafenib in combination with standard dosing TMZ.
- To estimate the median time to progression in all patients.
- To quantify the number and percent of patients who have stable disease after 6 months
of treatment (failure to progress).
- To choose the optimal combination dosing regimen for further study.
- To estimate and define the objective response rate in these patients.
- To characterize the duration of objective responses in these patients.
- To estimate the incidence of new symptomatic brain metastasis in these patients.
- To measure overall survival of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior brain
metastases (yes vs no) and prior treatment with temozolomide (TMZ) (yes vs no). Patients
with no prior brain metastases who did not receive prior treatment with TMZ are randomized
to 1 of 2 treatment arms. These patients are further stratified according to prior treatment
with sorafenib tosylate (yes vs no). Patients with or without prior brain metastases who
received prior treatment with TMZ are assigned to arm I. Patients with prior brain
metastases who did not receive prior treatment with TMZ are assigned to arm II.
- Arm I: Patients receive oral sorafenib tosylate twice daily on days -7 to 56 of course
1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily
on days 1-42.
- Arm II: Patients receive sorafenib tosylate as in arm I and oral TMZ once daily on days
1-5 and 29-33.
In both arms, courses repeat every 8 weeks in the absence of disease progression or
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Amy Kramer, RN, MPA
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|