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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.
First Received: August 6, 2003   Last Updated: April 4, 2009   History of Changes
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

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

Resource links provided by NLM:


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

Additional Information:
Publications:
Study ID Numbers: CDR0000316428, SWOG-S0306
Study First Received: August 6, 2003
Last Updated: April 4, 2009
ClinicalTrials.gov Identifier: NCT00066612     History of Changes
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:
Urinary Tract Neoplasm
Kidney Cancer
Cystocele
Irinotecan
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Camptothecin
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Urethral Cancer
Urethral Neoplasms
Bladder Neoplasm
Kidney Diseases
Antineoplastic Agents, Phytogenic
Ureteral Neoplasms
Transitional Cell Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Kidney Diseases
Neoplasms by Histologic Type
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Camptothecin
Pharmacologic Actions
Carcinoma
Neoplasms
Urethral Neoplasms
Ureteral Neoplasms
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009