Clinical trial · Interventional
4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer
MVAC (Methotrexate, Vinblastine, Adriamycin, and Cisplatin) in Organ-Confined Bladder Cancer Based on p53 Status
NCT00005047CI-TRIAL-00028026terminatedPhase 3Results 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): Accrual was halted on the basis of the Data and Safety Monitoring Board review of a futility analysis.
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. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating bladder cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with 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 |
| methotrexate | Drug | Methotrexate | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I: M-VAC x 3
- description
- Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC
- interventionNames
- Drug: cisplatin
- Drug: doxorubicin hydrochloride
- Drug: methotrexate
- Drug: vinblastine
- type
- NO_INTERVENTION
- label
- Arm II: Observation
- description
- Patients with altered (+) p53, reconsented to randomization, randomized to observation
- type
- NO_INTERVENTION
- label
- Arm III: Observation
- description
- Patients with unaltered (-) p53
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder
* Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma)
* Margins must be negative for invasive or in situ TCC
* In situ TCC in the urethra or ureter(s) allowed provided margins are negative
* Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed
* Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed
* No invasive tumor into ureter(s) or urethra
* Must have potentially curable disease
* Must register within 9 weeks after surgery
* No metastatic disease by physical exam and chest x-ray or CT scan of the chest
* Eligible for randomization if:
* p53 gene alteration present
* Randomization occurs within 10 weeks after surgery
* Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy
* No metastatic disease by physical exam and chest x-ray or CT scan of the chest
* No prohibitive medical risk for chemotherapy
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-1 OR
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 4,000/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic
* SGOT or SGPT no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal
* Bilirubin normal
Renal
* Creatinine no greater than 1.8 mg/dL OR
* Creatinine clearance at least 50 mL/min
* Blood urea nitrogen normal
Cardiovascular
* No serious arrhythmias
* No congestive heart disease with New York Heart Association class III or IV status
* Randomization group:
* Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status
Other
* No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
* No concurrent advanced medical illness or psychologic disease
* No prohibitive medical risk for chemotherapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior systemic chemotherapy for bladder cancer
* At least 5 years since other prior systemic chemotherapy
* Prior intravesical therapy allowed
* Randomization group:
* Prior intravesical therapy allowed if administered prior to cystectomy
Endocrine therapy
* Not specified
Radiotherapy
* No prior pelvic irradiation
Surgery
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDvon Rundstedt FC, Mata DA, Groshen S, Stein JP, Skinner DG, Stadler WM, Cote RJ, Kryvenko ON, Godoy G, Lerner SP. Significance of lymphovascular invasion in organ-confined, node-negative urothelial cancer of the bladder: data from the prospective p53-MVAC trial. BJU Int. 2015 Jul;116(1):44-9. doi: 10.1111/bju.12997. Epub 2015 Mar 25. PMID 25413313