Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
PRIMARY OBJECTIVES:
I. To evaluate disease-free survival with pazopanib (pazopanib hydrochloride) as compared to
placebo, defined as the time from randomization to the development of recurrent disease,
second primary cancer (other than localized breast, localized prostate, or non-melanoma skin
cancer) or death from any cause for patients with metastatic renal cell carcinoma (RCC) with
no evidence of disease following metastasectomy.
SECONDARY OBJECTIVES:
I. To describe the overall survival of patients with advanced RCC randomly assigned to
receive placebo or pazopanib for one year following metastasectomy to no evidence of disease
(NED).
II. To describe treatment and (at recurrence) disease-related adverse events in the two
treatment arms.
III. To analyze quality-adjusted time without symptoms of disease or treatment (Q-TWiST) for
subjects in the two treatment arms.
IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney
cancer-related symptoms during and following treatment with pazopanib compared to placebo.
V. To explore the association between plasma trough levels of pazopanib and disease-free and
overall survival.
VI. To prospectively bank preserved tissue from primary tumors and associated metastatic
sites in patients with RCC.
OUTLINE: Patients are randomized to 1of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28.
Treatment repeats every 28 days for up to 13 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up
to 13 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for the first
two years, every 6 months for the next 3 years, and then annually up to 10 years.
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Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast
conserving surgery by conventional clinical criteria will provide important information
about the clinical and biologic relevance of occult disease identified by MRI alone.
Patients will be assigned to standard pre-operative breast cancer disease assessment without
the addition of MRI prior to breast conserving surgery or standard pre-operative breast
cancer disease assessment with the use of MRI prior to breast conserving surgery.
The primary objective is to compare the rates of local-regional recurrence (LRR) following
attempted breast conserving therapy in a cohort of women with triple negative or HER-2
amplified breast cancer randomized to preoperative staging with mammography (control arm) or
mammography plus breast MRI (MRI arm).
Secondary objectives are:
- To compare the re-operation rates following attempted breast conserving therapy between
women assessed preoperatively with breast MRI to those assessed without the use of
breast MRI
- To compare local recurrence rates between women who undergo BCT on the control arm to
women who undergo BCT on the MRI arm
- To compare the conversion rate to mastectomy secondary to persistent positive margins
or poor cosmesis within the first 6 months of attempting BCT (prior to the
administration of RT) between women assessed preoperatively with breast MRI to those
assessed without the use of breast MRI
- To compare the contralateral breast cancer rates in women randomized to preoperative
breast MRI to those not receiving pre-operative breast MRI
- To compare the disease-free survival rates between women assessed preoperatively with
breast MRI to those assessed without the use of breast MRI
- To compare breast cancer specific and overall survival outcomes of women assessed
preoperatively with breast MRI to those assessed without the use of breast MRI
- To estimate the rate of MRI-guided localization assisted surgery
- To estimate the rate of multi-centric disease in the index breast for women in the MRI
arm
- To evaluate the accuracy of index lesion characteristics and other factors in
predicting multi-centricity in the cohort randomized to breast MRI
- To assess the positive predictive values (PPV) of MRI in detecting ipsilateral
multi-centric disease and contralateral disease in women with breast cancer undergoing
preoperative breast MRI
- To estimate the false positive rate for detection of multiple foci of breast cancer by
MRI
All registered patients will be monitored for relapse and survival for 5 years from the date
of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from
diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for
local, regional, distant relapse and vital status.
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A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma
PRIMARY OBJECTIVES:
I. To determine if patients with advanced transitional cell carcinoma treated with
bevacizumab, gemcitabine (gemcitabine hydrochloride) and cisplatin will have increased
overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.
SECONDARY OBJECTIVES:
I. To compare the progression-free survival of these two regimens in patients with advanced
transitional cell carcinoma.
II. To compare the proportion of patients who experience an objective response on each
regimen.
III. To compare the grade 3 and greater toxicities in patients treated on the two regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days
1 and 8, cisplatin IV over 1 hour, and placebo IV over 30-90 minutes on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence
of disease progression or unacceptable toxicity.
ARM II: Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also
receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6
courses in the absence of disease progression or unacceptable toxicity. Patients then
receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 7
years.
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