Clinical trial · Interventional
Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC
A Phase II Study of Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced Transitional Cell Carcinoma
NCT00173862CI-TRIAL-00000809completedPhase 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)
The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as second line chemotherapy in advanced transitional cell carcinoma in terms of response rate and overall survival .
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 |
|---|---|---|---|
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Ifosfamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Gemcitabine, Ifosfamide
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 2000~2006
Secondary outcomes (1)
- measure
- Overall Survival, Safety
- timeFrame
- 2000~2006
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed transitional cell carcinoma * Advanced / metastatic disease failed to prior chemotherapy (diagnostically confirmed disease progression during the treatment of last chemotherapy or within 6 months after the end of last chemotherapy) * Presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ³ 20 mm with conventional technique or ³ 10 mm with spiral CT scan * Performance status of ECOG 0, 1, 2 * Age 20 years or older * Life expectancy more than 3 months * Adequate hematopoietic function as defined below: * WBC ³ 3,000/uL * Platelets ³ 75,000/Ul * Adequate organ function as defined below: * Total bilirubin £ 1.5 ´ ULN * ALT / AST£ 5 ´ ULN * Creatinine £ 1.5 mg/dL * Adequate serum electrolyte concentration: * 4 mmol/L\<\[K+\] \<5.3 mmol/L * 0.74 mmol/L\<\[Mg2+\] \<1.03 mmol/ * 2.02 mmol/L\<\[Ca2+\]\<2.60 mmol/L * Result of ECG assessment: QTC \< 460 msec * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Received chemotherapy, radiotherapy, surgery, or other investigational drug within 4weeks prior to entering the study * Receiving other concurrent palliative chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period * Presence of CNS metastasis * Previous or current malignancy with the exception of curatively treated non- melanoma skin cancer or cervical carcinoma in situ * Presence of serious concomitant illness which might be aggravated by study medication: 1. Uncontrolled infection (active serious infections that are not controlled by antibiotics) 2. Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy) 3. Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec) 4. Prior myocardial infarction or serious coronary arterial disease within the last 12 months * Mental status is not fit for clinical trial. * Women of child-bearing potential (pregnancy or breast feeding)
References
Publications (0)
Data not yet available
No reference posted for this study.