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Gefitinib Plus Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041106
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: cisplatin
Drug: gefitinib
Drug: gemcitabine hydrochloride
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

ChemIDplus related topics:   Cisplatin    Gemcitabine hydrochloride    Gemcitabine    ZD1839   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Cisplatin, Gemcitabine, And ZD 1839 (IRESSA) (IND #61187; NSC 715055) For The Treatment Of Advanced Urothelial Tract Carcinoma

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

Study Start Date:   July 2002

Detailed Description:

OBJECTIVES:

  • Determine the overall response rate in patients with metastatic transitional cell carcinoma of the urothelium treated with cisplatin, gemcitabine, and gefitinib.
  • Determine the time to progression, progression-free survival, and overall survival in patients treated with this regimen.
  • Determine the effect of epidermal growth factor receptor expression level on overall response rate and progression-free survival in patients treated with this regimen.
  • Determine the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Patients also receive oral gefitinib once daily beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission, partial remission, or maintain stable disease continue oral gefitinib once daily for 5 years or until disease progression or unacceptable toxicity occurs.

Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse.

PROJECTED ACCRUAL: A total of 12-50 patients will be accrued for this study within 12-18 months.

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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma of the urothelium (bladder, ureter, renal pelvis or urethra)

    • Metastatic disease (N2, N3, or M1)
    • Histologic confirmation of metastatic/recurrent disease is not required
  • Not amenable to potentially curative surgery or radiotherapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Bladder not considered a site of measurable disease
    • Nonmeasurable lesions include:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • No evidence of brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • AST/ALT less than 2 times ULN
  • No active severe chronic liver disease

Renal:

  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing sensory or motor neuropathy greater than grade 1
  • No ongoing or active infection
  • No active severe chronic gastrointestinal disorders, including diarrheal or emetic disorders or malabsorptive conditions causing nausea or diarrhea
  • No active severe chronic desquamative cutaneous disorders
  • No active severe corneal disease or inflammatory ocular disorders
  • No other concurrent active malignancy except nonmelanoma skin cancer
  • HIV negative
  • No psychiatric illness or social situations that would preclude compliance
  • No other uncontrolled concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior systemic therapies for advanced carcinoma of the urothelium, including investigational agents targeting the HER2/neu, signal transduction, angiogenic, immune, and cell cycle pathways
  • No concurrent immunotherapy

Chemotherapy:

  • No prior systemic chemotherapy except single-agent chemotherapy used as a radiosensitizer
  • No prior adjuvant or neoadjuvant chemotherapy
  • Prior intravesical chemotherapy allowed
  • More than 4 weeks since prior intravesical chemotherapy and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • More than 7 days since prior dexamethasone
  • No concurrent hormonal therapy except:

    • Steroids for adrenal failure
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic

Radiotherapy:

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy, including palliative radiotherapy

Surgery:

  • More than 4 weeks since prior major surgery and recovered

Other:

  • No prior gefitinib
  • No prior investigational epidermal growth factor receptors for advanced carcinoma of the urothelium
  • More than 7 days since prior CYP3A4 inducers, including phenytoin, carbamazepine, barbiturates, rifampin, Hypericum perforatum, modafinil, or rifapentine
  • No concurrent CYP3A4 inducers, including phenytoin, carbamazepine, barbiturates, rifampin, Hypericum perforatum, modafinil, or rifapentine
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041106

Show 82 study locations  Show 82 Study Locations

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     George Philips, MD, MPH     Fletcher Allen Health Care - University Health Center Campus    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Philips GK, Halabi S, Sanford BL, Bajorin D, Small EJ; Cancer and Leukaemia Group B. A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102. BJU Int. 2007 Oct 8; [Epub ahead of print]
 
Philips G, Sanford B, Halabi S, et al.: Phase II study of cisplatin (C), gemcitabine (G) and gefitinib for advanced urothelial carcinoma (UC): analysis of the second cohort of CALGB 90102. [Abstract] J Clin Oncol 24 (Suppl 18): A-4578, 2006.
Philips G, Halabi S, Sanford B, et al.: Phase II trial of cisplatin (C), fixed-dose rate gemcitabine (G) and gefitinib for advanced transitional cell carcinoma (TCC) of the urothelial tract: preliminary results of CALGB 90102. [Abstract] J Clin Oncol 22 (Suppl 14): A-4540, 391s, 2004.

Study ID Numbers:   CDR0000069443, CALGB-90102
First Received:   July 8, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00041106
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma
Urethral cancer
Cisplatin
Urologic Diseases
Kidney Neoplasms
Urethral Neoplasms
Kidney Diseases
Gemcitabine
Gefitinib
Ureteral Neoplasms
Urinary tract neoplasm
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Urethral Diseases

ClinicalTrials.gov processed this record on August 20, 2008




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