ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066612
  Purpose

RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.


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

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

ChemIDplus related topics:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

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

Primary Outcome Measures:
  • Objective response rate as measured by RECIST criteria every 6-9 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as measured by CTC every 3 weeks [ Designated as safety issue: Yes ]

Estimated Enrollment:   40
Study Start Date:   July 2003

Detailed Description:

OBJECTIVES:

  • Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the overall and progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 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 (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra

    • Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease
    • The following additional histologic subtypes are eligible:

      • Poorly differentiated TCC
      • Predominant TCC with rare foci of squamous differentiation
      • Predominant TCC with rare foci of adenocarcinoma
    • The following histologic subtypes are ineligible:

      • Adenocarcinoma
      • Small cell carcinoma
      • Sarcoma
      • Squamous cell carcinoma
      • Mixed adeno/squamous/transitional histology
  • Incurable by surgery or radiotherapy
  • Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease
  • Measurable disease

    • Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
  • No uncontrolled CNS metastases

    • CNS metastases that have responded to or stabilized after prior radiotherapy are allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT less than 3 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine less than 2 times ULN

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • At least 28 days since prior chemotherapy
  • No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy to the pelvis

Surgery

  • Not specified

Other

  • Recovered from prior therapy
  • Prior adjuvant therapy allowed
  • At least 14 days since prior Hypericum perforatum (St. John's Wort)
  • More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs)
  • No St. John's Wort during and for 7 days after study participation
  • No concurrent EIACDs
  • No concurrent myelosuppressants
  • No concurrent medications that cause diarrhea
  • Concurrent gabapentin or other non-EIACDs are allowed
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066612

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Investigator:     Tomasz M. Beer, MD     Oregon Health and Science University Cancer Institute    
Investigator:     Craig R. Nichols, MD     Oregon Health and Science University Cancer Institute    
  More Information

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

Publications of Results:

Study ID Numbers:   CDR0000316428, SWOG-S0306
First Received:   August 6, 2003
Last Updated:   June 4, 2008
ClinicalTrials.gov Identifier:   NCT00066612
Health Authority:   United States: Federal Government

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

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Urethral Diseases
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers