Clinical trial · Interventional
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
NCT00350025CI-TRIAL-00026719completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial 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 |
|---|---|---|---|
| Urologic Neoplasm | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cetuximab alone
- description
- Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
- interventionNames
- Drug: Cetuximab
- type
- OTHER
- label
- Cetuximab with Paclitaxel
- description
- Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
- interventionNames
- Drug: Cetuximab
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter) * Measurable disease by RECIST * Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease. * Signed IRB approved consent * Must have tissue available for EGFR assessment and additional correlative studies * ECOG PS 0-2 * 18 years of age or older * Not of child bearing potential or negative pregnancy test within 7 days of treatment * ANC greater than or equal to 1,500/ul * Platelets greater than or equal to 100,00/ul * Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST\&ALT less than or equal to 5x ULN Exclusion Criteria: * Received more than one prior regimen for advanced disease * Prior radiation to more than 30% of marrow containing skeleton * Prior therapy that specifically and directly targets the EGFR pathway * Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2 * Prior reaction to Cremophor EL * Known acute hepatitis B or C or known HIV * Active or uncontrolled infection * Significant history of uncontrolled cardiac disease * Any concurrent chemotherapy not indicated in this study; or * Any other investigational agents
References
Publications (1)
- RESULTWong YN, Litwin S, Vaughn D, Cohen S, Plimack ER, Lee J, Song W, Dabrow M, Brody M, Tuttle H, Hudes G. Phase II trial of cetuximab with or without paclitaxel in patients with advanced urothelial tract carcinoma. J Clin Oncol. 2012 Oct 1;30(28):3545-51. doi: 10.1200/JCO.2012.41.9572. Epub 2012 Aug 27. PMID 22927525