Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Uro… (NCT01261728) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
United States57 participantsStarted 2010-12-14
Plain-language summary
The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed high-grade upper tract transitional cell carcinoma at MSKCC or a participating site and/or radiographically visible tumor stage T2-T4a N0/X M0 disease with positive selective urinary cytology or high-grade concomitant bladder tumor. Hydronephrosis associated with tumor on biopsy will be considered invasive by definition.
* Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per MSKCC or a participating site attending urologic oncologist
* Karnofsky Performance Status ≥ 70%
* Age ≥ 18 years of age
* Required Initial Laboratory Values:
* Absolute neutrophil count ≥ 1500 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 9.0g/dL
* Bilirubin ≤ 1.2
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution
* Alkaline phosphatase ≤ 2.5 x ULN for the institution
* Serum creatinine ≤ 1.3 mg/dL if male or ≤ 1.1 mg/dL if female OR calculated creatinine clearance ≥ 55 ml/min/1.73m\^2 If female of childbearing potential, serum pregnancy test is negative.
* Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
ml/min/1.73m2 using the formula: CKD epi : GFR = 141 X min(Scr/κ,1)α X max(Scr/κ,1)-1.209 X 0.993Age X 1.018 \[if female\] X 1.159 \[if black\]
* Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr…
What they're measuring
1
To define the pathologic response rate (<pT2)
Timeframe: The time to disease progression is measured from the time of initiation of chemotherapyuntil the first date that systemic recurrence is objectively documented.