This is a study for patients with advanced testicular cancer. This research study involves treatment with oxaliplatin, paclitaxel, and gemcitabine, which is an investigational chemotherapy combination. This study is for patients who have not responded to standard cisplatin-containing chemotherapy or the cancer has returned after such treatment. This research is being done to assess the effectiveness of the proposed combination of medications for this type of cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1. Paclitaxel 170 mg/m2 IV d 1 14 days 2. Gemcitabine 800 mg/m2 IV d 1 14 days 3. Oxaliplatin 100 mg/m2 IV d 1 14 days
Norris Comprehensive Cancer Center
Los Angeles, California, United States
Tumor Response
Defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the sum of the diameters of the target lesions compared to the baseline; Stable Disease = Neither enough shrinkage for PR nor enough growth for PD; Progressive Disease = at least a 20% increase in the sum of the diameters of the target lesions from the smallest measurement recorded, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions.
Time frame: From start of study drug until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 weeks, through study completion, up to 9 years
Progression-Free Survival
Progression-free survival measures the length of time a patient with cancer does not experience disease progression or death.
Time frame: Through study completion, about 9 years
Overall Survival
Measuring Overall Survival
Time frame: Through study completion, about 9 years
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