Phase II Study of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine and Cisplatin
- Conditions
- Urothelial Carcinoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 57
- Locations
- 9
- Primary Endpoint
- To define the pathologic response rate (<pT2)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Concomitant bladder urothelial carcinoma is acceptable if it is organ confined and surgically resectable.
- •Presence of carcinoma in situ (CIS)
- •Prior systemic chemotherapy (prior intravesical therapy is allowed)
- •Prior radiation therapy to the bladder
- •Evidence of NYHA functional class III or IV heart disease.
- •Serious intercurrent medical or psychiatric illness, including serious active infection.
- •Preexisting sensory grade 3 neuropathy
- •Major surgery or radiation therapy \< 4 weeks of starting study treatment.
- •Concomitant use of any other investigational drugs
- •Any of the following within the 6 months prior to study drug administration:
Arms & Interventions
Gemcitabine and Cisplatin
This is a Phase II Study of Gemcitabine and Cisplatin (GC) as neoadjuvant chemotherapy in patients with upper tract high-grade urothelial carcinoma who are candidates for radical nephroureterectomy or distal ureterectomy.
Intervention: Gemcitabine and Cisplatin
Outcomes
Primary Outcomes
To define the pathologic response rate (<pT2)
Time Frame: The time to disease progression is measured from the time of initiation of chemotherapyuntil the first date that systemic recurrence is objectively documented.
of neoadjuvant Gemcitabine and Cisplatin regimen in patients with upper tract high-grade urothelial carcinoma. And is defined as the absence of high-grade carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final nephroureterectomy specimen.
Secondary Outcomes
- To determine the time to disease progression(Time to progression is measured from the time of initiation of chemotherapy until the 1st date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.)
- To determine overall survival of patients(3 years)
- To evaluate the safety and tolerability(every 2 weeks per cycle)