Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer

NCT00696007 | Withdrawn Phase 2

• 1 other identifier: 2008-039
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.

Conditions

Transitional Cell Carcinoma

Keywords

Upper GU Tract Transitional Cell Carinoma; Nephroureterectomy; Chemotherapy; Gemcitabine; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Neoadjuvant chemotherapy (Gemcitabine and Cisplatin) Regime (3 cycles) before Nephroureterectomy

  5 years: follow ups 1st year/every 4 mths, 2nd & 3rd year to every 6 months, 4th & 5th yr-annually for patients who remain disease free

Secondary Outcomes (1)

• Overall survival compared to institutional historical cohort of subjects who have undergone a nephroureterectomy alone.

  5 years

Study Arms (2)

1

EXPERIMENTAL

A neoadjuvant chemotherapy (gemcitabine and cisplatin) regimen administered before surgery-nephroureterectomy for upper tract TCC

Drug: Gemcitabine and cisplatin

2

OTHER

A retrospective cohort group (approximately 60 subjects) identified from an institutional cancer registry who have undergone a nephroureterectomy alone over the past five years

Other: Retrospective comparison

Interventions

Gemcitabine and cisplatin DRUG

Neoadjuvant chemotherapy (gemcitabine and cisplatin) administered before Nephroureterectomy. Chemotherapy regimen of three cycles of gemcitabine and cisplatin, dosed over a 3 month period Each cycle would consist of gemcitabine and cisplatin on day 1, with two other doses of gemcitabine on day 8 and day 15. Gemcitabine dosing would be 1,000 mg/m² and cisplatin would be dosed at 70 mg/m²

Also known as: Neoadjuvant Chemotherapy

1

Retrospective comparison OTHER

60 retrospective historical cohort group of subjects who have undergone a radical nephroureterectomy over the past five years

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0-2
• Estimated GFR\>60
• High grade TCC on initial biopsy
• Clinical stage T1-T3, Nx, Mx based on the AJCC Classification system
• TCC confined to the ureter or renal pelvis
• Grade II neuropathy or less

You may not qualify if:

• Any other malignancy over the previous five years with a risk of relapse that exceeds 30%
• History of previous cystectomy
• Evidence of metastatic disease
• History of pelvic irradiation or prior chemotherapy

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (7)

• Splinter TA, Pavone-Macaluso M, Jacqmin D, Roberts JT, Carpentier P, de Pauw M, Sylvester R. A European Organization for Research and Treatment of Cancer--Genitourinary Group phase 2 study of chemotherapy in stage T3-4N0-XM0 transitional cell cancer of the bladder: evaluation of clinical response. J Urol. 1992 Dec;148(6):1793-6. doi: 10.1016/s0022-5347(17)37031-3.

  PMID: 1433610 BACKGROUND

• Raman JD, Sosa RE, Vaughan ED Jr, Scherr DS. Pathologic features of bladder tumors after nephroureterectomy or segmental ureterectomy for upper urinary tract transitional cell carcinoma. Urology. 2007 Feb;69(2):251-4. doi: 10.1016/j.urology.2006.09.065.

  PMID: 17320658 BACKGROUND

• Brown GA, Busby JE, Wood CG, Pisters LL, Dinney CP, Swanson DA, Grossman HB, Pettaway CA, Munsell MF, Kamat AM, Matin SF. Nephroureterectomy for treating upper urinary tract transitional cell carcinoma: Time to change the treatment paradigm? BJU Int. 2006 Dec;98(6):1176-80. doi: 10.1111/j.1464-410X.2006.06524.x.

  PMID: 17125474 BACKGROUND

• Keeley FX, Kulp DA, Bibbo M, McCue PA, Bagley DH. Diagnostic accuracy of ureteroscopic biopsy in upper tract transitional cell carcinoma. J Urol. 1997 Jan;157(1):33-7.

  PMID: 8976209 BACKGROUND

• Hall MC, Womack S, Sagalowsky AI, Carmody T, Erickstad MD, Roehrborn CG. Prognostic factors, recurrence, and survival in transitional cell carcinoma of the upper urinary tract: a 30-year experience in 252 patients. Urology. 1998 Oct;52(4):594-601. doi: 10.1016/s0090-4295(98)00295-7.

  PMID: 9763077 BACKGROUND

• Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. doi: 10.1056/NEJMoa022148.

  PMID: 12944571 BACKGROUND

• Igawa M, Urakami S, Shiina H, Kishi H, Himeno Y, Ishibe T, Kadena H, Usui T. Neoadjuvant chemotherapy for locally advanced urothelial cancer of the upper urinary tract. Urol Int. 1995;55(2):74-7. doi: 10.1159/000282755.

  PMID: 8533199 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Gemcitabine; Cisplatin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Christopher G. Tretter, M.D.

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)