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

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

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

Study Chair:

Tomasz M. Beer, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

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

Publications:

Beer TM, Goldman B, Nichols CR, Petrylak DP, Agarwal M, Ryan CW, Crawford ED; Southwest Oncology Group. Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy. Clin Genitourin Cancer. 2008 Mar;6(1):36-9.

Responsible Party:	Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier:	NCT00066612 History of Changes
Other Study ID Numbers:	CDR0000316428, U10CA032102, SWOG-S0306
Study First Received:	August 6, 2003
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases

Kidney Diseases
Ureteral Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012