S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy

October 31, 2012 updated by: Southwest Oncology Group

Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 central nervous system (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)
  • Aspartate aminotransferase (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 medications that cause myelosuppression
  • No concurrent medications that cause diarrhea
  • Concurrent gabapentin or other non-EIACDs are allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Irinotecan
Drug: irinotecan hydrochloride
Irinotecan will be given 250 mg/m^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probability of response (confirmed complete and partial response)
Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and grade of adverse events
Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Overall survival
Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Progression-free survival
Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000316428
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0306 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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