Clinical trial · Interventional
Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer
Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma
NCT00645593CI-TRIAL-00022330completedPhase 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)
This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine, | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1, Gemcitabine and Cisplatin
- description
- Gemcitabine and Cisplatin, as described in the intervention
- interventionNames
- Drug: Gemcitabine,
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Arm 2, Cetuximab, Gemcitabine and Cisplatin
- description
- Gemcitabine and Cisplatin with Cetuximab, as described in the intervention
- interventionNames
- Drug: Gemcitabine,
- Drug: Cisplatin
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Study participants will be male or female at least 18 years of age * Study participants will have a histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma; either pure or mixed histology) that is metastatic, locally recurrent, or unresectable (T4bN0 or any T, N2030) * Study participants must have measurable disease by radiologic imaging. Study participants that have received previous radiation therapy, recovered from side effects and have not had more than 25% of the bone marrow * Study participants must have adequate bone marrow function Exclusion Criteria: * Study participants may not have received previous systemic chemotherapy for the current stage of disease with the following exception: prior neoadjuvant or adjuvant chemotherapy is allowed provided it has been at least 6 months since treatment with non-cisplatin containing regimens and \> 1 year since treatment with a cisplatin containing regimen * Study participants may not have received prior therapy targeting the EGFR pathway * Study participants may not have a history or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan * Study participants may not have known HIV due to the intense nature of the chemotherapy in this trial * Study subjects may not have a history of congestive heart failure (CHF), chronic renal failure, active TIAs, recent (in the last 6 months) stroke, symptomatic pulmonary embolism (PE), or myocardial infarction. * Study participants with history of DVT or incidental or asymptomatic PE will be eligible for the study as deemed appropriate by the treating physician provided they continue prophylactic or full dose anticoagulation as per standards of care for the specific event. * Study participants must not have a prior grade 3 or 4 severe infusion reaction to monoclonal antibodies * Study participants may not be pregnant or breastfeeding * Study participants may not receive concurrent treatment on another therapeutic clinical trial.
References
Publications (1)
- DERIVEDHussain M, Daignault S, Agarwal N, Grivas PD, Siefker-Radtke AO, Puzanov I, MacVicar GR, Levine EG, Srinivas S, Twardowski P, Eisenberger MA, Quinn DI, Vaishampayan UN, Yu EY, Dawsey S, Day KC, Day ML, Al-Hawary M, Smith DC. A randomized phase 2 trial of gemcitabine/cisplatin with or without cetuximab in patients with advanced urothelial carcinoma. Cancer. 2014 Sep 1;120(17):2684-93. doi: 10.1002/cncr.28767. Epub 2014 May 6. PMID 24802654