Clinical trial · Interventional
Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and amifostine following surgery in treating patients who have locally advanced bladder cancer.
Conditions
Conditions (2)
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 |
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| amifostine trihydrate | Drug | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of Cisplatin, Gemcitabine, and Amifostine
- description
- Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
- interventionNames
- Drug: amifostine trihydrate
- Drug: cisplatin
- Drug: gemcitabine hydrochloride
- Procedure: adjuvant therapy
Primary outcomes (1)
- measure
- Side effects of cisplatin/gemcitabine in combination with amifostine
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Completely resected locally advanced bladder cancer * T2-4, N0-2 * Post radical cystectomy with no gross residual disease * No evidence of metastases by CT of chest, abdomen, and pelvis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * No serious concurrent systemic disorders that would preclude study participation * No metastatic cancer in past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except contraceptives and replacement steroids Radiotherapy: * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 but no more than 8 weeks since radical cystectomy Other: * No other concurrent experimental medications
References
Publications (0)
Data not yet available