Clinical trial · Interventional
Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer
Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic 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)
The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.
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 |
|---|---|---|---|
| Carcinoma, Transitional Cell | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Platinol | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity will be measured by standard grading methods.
Secondary outcomes (5)
- measure
- Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
- measure
- Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.
- measure
- Time to progressive disease is defined as time from enrollment to first date of disease progression.
- measure
- Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.
- measure
- Survival time is defined as time from enrollment to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven metastatic bladder cancer * No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment * Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment * 18 years of age and older Exclusion Criteria: * Pure adeno- or squamous urothelial cancer * Brain metastases that causes symptoms * Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol * Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
References
Publications (0)
Data not yet available