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Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
Phase 2 trial testing gemcitabine hydrochloride in Distal Urethral Cancer in 32 participants. Terminated before completion.
| Lead sponsor | Fox Chase Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 29 May 2012 |
| Primary completion | 12 July 2013 |
| Estimated completion | 22 January 2019 |
| Sites | 2 locations across United States |
Fox Chase Cancer Center — full company profile →
18 and older, any sex, with Distal Urethral Cancer or Proximal Urethral Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery) | 32 | 16 – 48 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Gemcitabine Hyd… |
|---|---|---|
| Fever | General disorders | — |
| Chest pain | Cardiac disorders | — |
| Deep Vein Thrombosis | Vascular disorders | — |
| hyperkalemia | Metabolism and nutrition disorders | — |
| vomiting | Gastrointestinal disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Acute Renal Insufficiency | Blood and lymphatic system disorders | — |
| Coronary Artey Disease | Cardiac disorders | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Myocardial Infarction | Cardiac disorders | — |
| hypotension | Vascular disorders | — |
| Pulmonary embolism | Vascular disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| infected lymphocele | Infections and infestations | — |
| Nausea | Gastrointestinal disorders | — |
| bacteremia | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| hypernatremia | Metabolism and nutrition disorders | — |
| hyperglycemia | Metabolism and nutrition disorders | — |
| Ileus | Gastrointestinal disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Gout | Musculoskeletal and connective tissue disorders | — |
| hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| cerebral Infarction | Blood and lymphatic system disorders | — |
| Reaction | System | Treatment (Gemcitabine Hyd… |
|---|---|---|
| fatigue | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypomagnesium | Metabolism and nutrition disorders | — |
| Alkaline Phosphatase increased | Investigations | — |
| creatinine increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| lymphocyte count decreased | Investigations | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Anxiety | Psychiatric disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Platelet count decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Tinnitus | Eye disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Edema | General disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| vomiting | Gastrointestinal disorders | — |
| chills | General disorders | — |
| fever | General disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Sinus Trachycardia | Cardiac disorders | — |
| Ileus | Gastrointestinal disorders | — |
| Mucositis | Gastrointestinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| ALT/SGPT | Investigations | — |
| White blood cells decreased | Investigations | — |
| ANC decreased | Investigations | — |
| Hypotension | Vascular disorders | — |
| AST/SGOT | Investigations | — |
| Injection site reaction | General disorders | — |
Most-reported serious reactions: Fever, Chest pain, Deep Vein Thrombosis, hyperkalemia, vomiting, Acute Kidney Injury, Constipation, Acute Renal Insufficiency.
Data from ClinicalTrials.gov NCT01611662 adverse events section.
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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