Clinical trial · Interventional
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
NCT00053209CI-TRIAL-00067424completedPhase 2ClinicalTrials.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)
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
Conditions
Conditions (3)
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 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed Disodium and Gemcitabine
- description
- Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: pemetrexed disodium
Primary outcomes (1)
- measure
- Response as measured by RECIST criteria
- timeFrame
- Assessed every 6 weeks
Secondary outcomes (2)
- measure
- Time to disease progression
- timeFrame
- Assessed every 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra)
* Any of the following types:
* Transitional cell carcinoma (TCC)
* Mixed histologies containing a component of TCC
* Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra)
* Progressing regional or metastatic disease
* Measurable disease
* No clinical evidence of CNS metastases
* No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic
* AST no greater than 3 times upper limit of normal (ULN)
* Bilirubin no greater than 1.5 times ULN
Renal
* Creatinine clearance at least 45 mL/min
Cardiovascular
* No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease)
* No uncontrolled congestive heart failure
* No ventricular dysrhythmias
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active unresolved infection
* No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time
* Able and willing to receive folic acid and cyanocobalamin supplementation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior systemic biologic response modifier therapy
Chemotherapy
* No prior systemic chemotherapy for metastatic disease
* More than 1 year since prior neoadjuvant or adjuvant chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
* No prior pelvic radiotherapy
* No concurrent radiotherapy
Surgery
* At least 4 weeks since prior major surgery and recovered
Other
* More than 7 days since prior parenteral antibiotics
* No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium
* No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodiumReferences
Publications (2)
- RESULTDreicer R, Li H, Cooney MM, Wilding G, Roth BJ; Eastern Cooperative Oncology Group. Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802): a trial of the Eastern Cooperative Oncology Group. Cancer. 2008 Jun 15;112(12):2671-5. doi: 10.1002/cncr.23503. PMID 18459175
- RESULTLi S, Dreicer R, Roth B, et al.: Phase II trial of pemetrexed disodium and gemcitabine in advanced carcinoma of the urothelium (E4802): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-5079, 254s, 2007.