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Trial record 26 of 32 for:    "Urethra Cancer" | "Antimetabolites, Antineoplastic"

Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478361
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : June 22, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
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 Drug: Gemcitabine hydrochloride Drug: Paclitaxel Drug: Doxorubicin hydrochloride Drug: Pegfilgrastim Phase 2

Detailed Description:


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.


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 intravenous (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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
Drug: Gemcitabine hydrochloride
Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days.
Other Names:
  • dFdC
  • difluorodeoxycytidine hydrochloride
  • gemcitabine
  • Gemzar

Drug: Paclitaxel
135 mg/m^2 IV over 1 hour
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Drug: Doxorubicin hydrochloride
Doxorubicin 40 mg/m^2 IV over 20 minutes
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF

Drug: Pegfilgrastim
Subcutaneously injection on day 1.
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
  • SD-01 sustained duration G-CSF

Primary Outcome Measures :
  1. Overall response rate (complete and partial response) [ Time Frame: Up to 12 weeks ]
    Overall response defined as participants with Complete or Partial Response using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response: Disappearance of all target lesions. Partial Response: At least 30% decrease in sum of longest diameter of target lesions, reference baseline sum longest diameter. Progressive Disease: At least a 20% increase in sum of longest diameter of target lesions, reference smallest sum longest diameter recorded since treatment started or appearance of 1 or > new lesions. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.

  2. Time to progression [ Time Frame: Up to 3 years ]
    Time measured in months from the date of protocol registration to disease progression, assessed up to 3 years

  3. Survival duration [ Time Frame: 3 years ]
    Time measured from the date of protocol registration to death, assessed up to 3 years

  4. Frequency of neutropenic fever or treatment delay because of neutropenia [ Time Frame: Up to 3 years ]
    Safety and efficacy of pegfilgrastim administered on the day of chemotherapy measured by the frequency of neutropenic fever or treatment delay because of neutropenia

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478361

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United States, Missouri
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Lance Pagliaro, MD, BA M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00478361     History of Changes
Obsolete Identifiers: NCT00477438
Other Study ID Numbers: 2005-0839
NCI-2009-00154 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
2U10CA045809-17 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Albumin-Bound Paclitaxel
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action