Clinical trial · Interventional
Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy
- 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 gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone 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 |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine,
- description
- •Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
- interventionNames
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Gemcitabine, Oxaliplatine
- description
- •Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: oxaliplatin
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract * Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1) * Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2 * At least 1 unidimensionally measurable lesion according to RECIST criteria * No nonmeasurable lesions only, including any of the following: * Ascites * Pleural or pericardial effusion * Bone metastases * Lymphangitis * No symptomatic cerebral metastases unless they have been stabilized PATIENT CHARACTERISTICS: * See Disease Characteristics * Performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present) * Transaminases ≤ 2 times normal (5 times normal if hepatic metastases present) * Bilirubin ≤ 1.5 times normal * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after completion of treatment * No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer * No peripheral neuropathy ≥ grade 2 * No uncontrolled infection * No other medical conditions that could interfere with evaluating tolerability, including any of the following: * Congestive heart failure * Angina pectoris that cannot be stabilized with medication * Myocardial infarction within the past 12 months * Serious thromboembolic disease * No psychologic, social, or geographic reason that would make follow-up impossible PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for advanced disease * More than 4 weeks since prior radiotherapy to a target measurable lesion
References
Publications (0)
Data not yet available