Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease.
SECONDARY OBJECTIVES:
I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 criteria) of the GE regimen in these patients.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 36 months.
A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic
sampling of the neck lymph nodes in patients with head and neck cancer planning to
undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult
metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local
sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary
tumors, or intensity of FDG uptake) that can lead to identification of subsets of
patients that could potentially forego neck dissection or that can provide preliminary
data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer
vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body
PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose
management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to
metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct
assessment of their prediction of recurrence, disease-free survival, and overall
survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels
that clinicians intend to dissect beyond the initial surgery plan) based on
local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy
of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites
(defined by anatomic location).
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients
undergo unilateral or bilateral neck dissection.
Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months
after surgery.
Patients undergo blood and tissue sample collection periodically for biomarker analysis.
Patients are followed up periodically for up to 2 years after surgery.
Not recruiting | Head and Neck Cancers | Multisite
Powered by
SC CTSI