Clinical trial · Interventional
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
NCT00089128CI-TRIAL-00033734terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine and Irnotecan
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Response Proportion
- timeFrame
- From registration until time of complete response or partial response
Secondary outcomes (3)
- measure
- Duration of Response
- timeFrame
- From registration until disease progression among patients who had at least a partial response.
- measure
- Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma of the bladder
* Locally advanced or metastatic disease
* Unidimensionally measurable disease by physical exam or imaging study
* The following are not considered measurable disease:
* Bone only disease
* Pleural or peritoneal effusions
* CNS lesions
* Irradiated lesions unless disease progression was documented after radiotherapy
* Not amenable to surgery
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 2.0 mg/dL
Gastrointestinal
* No active inflammatory bowel disease
* No significant bowel obstruction
* No chronic diarrhea
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other active malignancy except nonmelanoma skin cancer
* No mental incapacitation or psychiatric illness that would preclude giving informed consent
* No other severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No more than 1 prior platinum-based chemotherapy regimen
* At least 4 weeks since prior chemotherapy
* No prior irinotecan or gemcitabine
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
Surgery
* Not specified
Other
* No concurrent participation in another clinical trialReferences
Publications (0)
Data not yet available
No reference posted for this study.