Clinical trial · Interventional
S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
NCT00066612CI-TRIAL-00008413completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Irinotecan
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Probability of response (confirmed complete and partial response)
- timeFrame
- From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (3)
- measure
- Number and grade of adverse events
- timeFrame
- From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (1)
- RESULTBeer 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