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

This study has been withdrawn prior to enrollment.
(Study was unable to recruit subjects meeting the study requirements.)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00696007
First received: June 10, 2008
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Transitional Cell Carcinoma
Drug: Gemcitabine and cisplatin
Other: Retrospective comparison
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Neoadjuvant chemotherapy (Gemcitabine and Cisplatin) Regime (3 cycles) before Nephroureterectomy [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival compared to institutional historical cohort of subjects who have undergone a nephroureterectomy alone. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A neoadjuvant chemotherapy (gemcitabine and cisplatin) regimen administered before surgery-nephroureterectomy for upper tract TCC
Drug: Gemcitabine and cisplatin

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

Other Name: Neoadjuvant Chemotherapy
2
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
60 retrospective historical cohort group of subjects who have undergone a radical nephroureterectomy over the past five years

Detailed Description:

This study will look at improving overall survival of those undergoing nephroureterectomy for upper tract TCC (transitional cell carcinoma, comparing the pathological response of tumors treated with Neoadjuvant Chemotherapy (gemcitabine and cisplatin) before surgery. There have been reported studies of neoadjuvant chemotherapy in the treatment of upper tract TCC, there have been no studies to date that include the chemotherapy agents gemcitabine and cisplatin that are currently indicated in treating TCC of the bladder in the neoadjuvant and adjuvant setting. These agents have been proven to have a better overall safety profile and tolerability allowing more patients to complete their regimens. Secondarily, study will compare disease free overall survival among patients treated with neoadjuvant chemotherapy and surgery versus surgery alone. This study may elucidate the potential benefit of these agents when treating TCC of the upper tracts and may provide a survival advantage in this specific patient population as compared to a historical cohort.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696007

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Christopher G. Tretter, M.D. Lahey Clinic, Inc.
  More Information

Publications:

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00696007     History of Changes
Other Study ID Numbers: 2008-039
Study First Received: June 10, 2008
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Upper GU Tract Transitional Cell Carinoma
Nephroureterectomy
Chemotherapy
Gemcitabine
Cisplatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014