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

NCT00066612 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000316428U10CA032102S0306
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Probability of response (confirmed complete and partial response)

  From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (3)

• Number and grade of adverse events

  From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

• Overall survival

  From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

• Progression-free survival

  From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

Study Arms (1)

Treatment

EXPERIMENTAL

Irinotecan

Drug: irinotecan hydrochloride

Interventions

irinotecan hydrochloride DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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. doi: 10.3816/cgc.2008.n.006.

  PMID: 18501081 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Tomasz M. Beer, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: July 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: May 1, 2010
• Last Updated: November 2, 2012

Record last verified: 2012-10