Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Bladder Cancer
Phase III Study Comparing Sequential Chemotherapy (AG-ITP) To Cisplatin And Gemcitabine As Adjuvant Treatment After Cystectomy For Transitional Cell Carcinoma Of The Bladder
- 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 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: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients who have advanced 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine + cisplatin
- interventionNames
- Drug: cisplatin
- Drug: gemcitabine hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine + Doxorubicin + Pegfilgrastim
- interventionNames
- Biological: filgrastim
- Drug: doxorubicin hydrochloride
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the bladder * Any T, N+, M0 OR * T3a-4a, N0, M0 * At least 6 weeks but no more than 3 months since prior complete resection of bladder * Cystoprostatectomy plus pelvic lymph node dissection in males * Cystectomy/total abdominal hysterectomy/bilateral salpingo-oophorectomy plus pelvic lymph node dissection in females * Negative surgical margins * Carcinoma in situ allowed * No partial cystectomy or transurethral bladder tumor resection as definitive loco-regional therapy * Prostate cancer detected in resected specimen allowed if post-operative PSA is no more than 0.05 mg/dL * No metastatic or recurrent disease by post-operative chest x-ray and CT scan of abdomen and pelvis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Hematopoietic: * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 150,000/mm\^3 Hepatic: * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST ≤ 2 times ULN Renal: * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Cardiovascular: * Normal cardiac function by history, physical exam, or chest radiograph * Left ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram, for prior cardiac disease * No New York Heart Association class III or IV heart disease * No serious cardiac arrhythmias including first-, second-, and third-degree heart block Other: * Negative pregnancy test * No uncontrolled infection * No other active cancer within the past 5 years except non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to bladder
References
Publications (0)
Data not yet available