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A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency


Phase 2
N/A
N/A
Open (Enrolling)
Both
Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder, Urethral Cancer Associated With Invasive Bladder Cancer

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Trial Information

A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency


PRIMARY OBJECTIVES:

I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride,
and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable
transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.

SECONDARY OBJECTIVES:

I. Assess the safety and tolerability of this regimen in these patients. II. Determine the
median time to progression in patients treated with this regimen.

III. Determine the median survival duration in patients treated with this regimen.

IV. Assess the safety and efficacy of pegfilgrastim in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin hydrochloride IV over 20 minutes, paclitaxel IV over 60
minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on
day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years.


Inclusion Criteria:



- Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the
bladder, urethra, or upper urinary tract

- Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma,
or sarcoma) allowed if present in < 50% of the biopsy specimen

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study, in keeping with the policies of the
institution.

- Measurable disease: may include radiographic detection of metastases in lymph nodes
(>= 1.5 cm) or liver or lung (>= 1.0 cm) OR pelvic mass palpable on examination under
anesthesia

- Creatinine clearance < 60 mL/min; no renal insufficiency that requires hemodialysis;
no renal insufficiency that is reversible in patients with tumor confined to the
primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy)

- Zubrod performance status 0-2

- Platelet count > 100,000/mm^3

- Absolute granulocyte count > 1,500/mm^3

- Bilirubin =< 2.0 mg/dL

- AST and ALT =< 2 times upper limit of normal

- LVEF > 40% OR normal EKG and no history of cardiac disease

- All patients must be evaluated in the Department of Genitourinary Medical Oncology at
M. D. Anderson Cancer Center or participating CCOP center prior to signing informed
consent.

- No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy

- Prior intravesicular chemotherapy allowed

Exclusion Criteria:

- No brain metastases

- Not pregnant or nursing

- No severe or uncontrolled infection

- No New York Heart Association class III-IV congestive heart failure, unstable angina,
or history of myocardial infarction within the past 6 months

- No peripheral neuropathy >= grade 2

- No persistently uncontrolled diabetes mellitus

- No chronic liver disease

- No HIV positivity

- No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3
years

- No overt psychosis, mental disability, or other condition that would preclude giving
informed consent

- No known sickle cell disease

- No uncontrolled severe hypertension

- Renal insufficiency that requires hemodialysis or renal insufficiency that is
reversible in patients with tumor confined to the primary site (i.e., that is
potentially resectable with neoadjuvant chemotherapy).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete and partial response)

Outcome Description:

The expected objective response rate with standard therapy for these patients is 0.25. We will estimate the objective response rate with a 95% confidence interval.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Lance Pagliaro

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

NCI-2009-00154

NCT ID:

NCT00478361

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Distal Urethral Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Proximal Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urethral Cancer Associated With Invasive Bladder Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Renal Insufficiency
  • Urethral Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030