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Gemcitabine, Paclitaxel, Doxorubicin, and Pegfilgrastim in Treating Patients With Metastatic or Unresectable Bladder Cancer or Urinary Tract Cancer and Kidney Dysfunction
This study is ongoing, but not recruiting participants.
First Received: May 23, 2007   Last Updated: May 13, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00478361
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

PURPOSE: This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction.


Condition Intervention Phase
Bladder Cancer
Neutropenia
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Biological: pegfilgrastim
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (complete and partial response) at 6 and 12 weeks [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Median time to progression [ Designated as safety issue: No ]
  • Median survival duration [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]
  • Frequency of neutropenic fever [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: April 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • Assess the safety and tolerability of this regimen in these patients.
  • Determine the median time to progression in patients treated with this regimen.
  • Determine the median survival duration in patients treated with this regimen.
  • 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.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  • Metastatic or unresectable disease
  • Measurable disease

    • 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)
  • No brain metastases

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • 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
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • 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 uncontrolled severe hypertension
  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy

    • Prior intravesicular chemotherapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478361

  Show 28 Study Locations
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Lance C. Pagliaro, MD M.D. Anderson Cancer Center
Investigator: Arlene Siefker-Radtke, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M. D. Anderson Cancer Center at University of Texas ( Lance C. Pagliaro )
Study ID Numbers: CDR0000544831, MDA-2005-0839, MDA-2005-0939
Study First Received: May 23, 2007
Last Updated: May 13, 2009
ClinicalTrials.gov Identifier: NCT00478361     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neutropenia
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
urethral cancer associated with invasive bladder cancer
anterior urethral cancer
posterior urethral cancer
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
regional transitional cell cancer of the renal pelvis and ureter
stage III bladder cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Ureteral Diseases
Urogenital Neoplasms
Leukocyte Disorders
Antibiotics, Antineoplastic
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Kidney Diseases
Gemcitabine
Neoplasms by Histologic Type
Hematologic Diseases
Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Agranulocytosis
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on November 30, 2009