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BRIEF TITLE: Study of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma

Phase II Study of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma


  • Org Study ID: 10-208
  • Secondary ID:
  • NCT ID: NCT01261728
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: Memorial Sloan Kettering Cancer Center

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.

Overal Status Start Date Phase Study Type
Recruiting December 14, 2010 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: To define the pathologic response rate (<pT2)

Primary Outcome 1 - 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.

Condition:

  • Urothelial Carcinoma

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. Hydronephrosis associated with tumor
on imaging or 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 ≤ 1.5

- 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 ≤ 1.5 mg/dL and calculated creatinine clearance ≥ 55 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/k or 1, and max
indicates the maximum of Scr/k or 1.

- 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

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:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2.

- Uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy).

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness or other active infection. Patients with HIV but no evidence of
AIDS will be considered candidates.

- Concurrent treatment on another clinical trial involving an intervention which may
affect the primary endpoint. Supportive care trials or non-treatment trials, e.g. QOL,
are allowed.

- Ongoing treatment with therapeutic doses of warfarin or low molecular weight heparin
(low dose warfarin up to 2 mg po daily or use of subcutaneous low molecular weight
heparin for thromboembolic prophylaxis is allowed).

- Pregnancy or breast-feeding. Patients must be surgically sterile or be postmenopausal,
or must agree to use effective contraception during the period of therapy. The
definition of effective contraception will be based on the judgment of the MSKCC and
participating site PI. Male patients must be surgically sterile or agree to use
effective contraception
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jonathan Coleman, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Jonathan Coleman, MD

Phone: 646-422-4432

Email:

Link: Memorial Sloan Kettering Cancer Center

Locations

Facility Status Contact
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Recruiting Thai Ho, MD

Hartford Hospital
Hartford, Connecticut
United States
Recruiting Robert Siegel, MD

Baptist Alliance MCI
Miami, Florida 33143
United States
Recruiting Antonio Muina, MD
786-596-2000
Henry Ford Hospital
Detroit, Michigan 48202
United States
Not yet recruiting Clara Hwang, MD

Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey 07920
United States
Recruiting Jonathan Coleman, MD
646-422-4432
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York 11725
United States
Recruiting Jonathan Coleman, MD
646-422-4432
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Recruiting Jonathan Coleman, MD
646-422-4432
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Jonathan Coleman, MD
646-422-4432
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
United States
Recruiting Jonathan Coleman, MD
646-422-4432
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Jonathan Coleman, MD
646-422-4432