Clinical trial · Interventional
Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer
A Phase 1-2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer
NCT01938573CI-TRIAL-00029993completedPhase 1 / Phase 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 phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cystectomy | Procedure | — | UNRESOLVED |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sirolimus, cisplatin, gemcitabine
- description
- Sirolimus day -2, cisplatin 70 mg/m2 IV Day 1 and gemcitabine hydrochloride 1000 mg/m2 IV days 1 and 8 every 21 days for 4 cycles followed by cystectomy (surgery)
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine Hydrochloride
- Drug: Sirolimus
- Procedure: Cystectomy
Primary outcomes (2)
- measure
- Patients With Dose Limiting Toxicity
- timeFrame
- Up to 28 days
- description
- Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).
- measure
- Percent of Patients With Pathologic Complete Response (Phase II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information * Histologically or cytologically confirmed carcinoma of the bladder of all histologies except neuroendocrine differentiation or squamous cell histology * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 * Eligibility for phase 1 and phase 2 components: * Phase 1 - clinical T3 or T4 or N1 or M1 cancer which is untreated or previously treated with platinum based therapy with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated * Phase 2 - clinical T2-4 N0 or N1 untreated with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated * Life expectancy \>= 12 weeks * No prior malignancy is allowed except: * Adequately treated basal cell or squamous cell skin cancer or * In situ carcinoma of any site or * Other adequately treated malignancy for which the patient is currently disease free for at least one year * Absolute neutrophil count \>= 1.5 x 10\^9 cells/L * Hemoglobin (Hgb) \>= 9.0 g/dL * Platelets \>= 100,000 x 10\^9/L * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 1.5 x upper limit of normal (ULN) * Bilirubin and total bilirubin levels =\< 1.5 x ULN * Serum creatinine \< 1.5 X institutional ULN mg/dL OR glomerular filtration rate (GFR) \>= 50 mL/min * All pre-study labs required for determination of eligibility are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday) * X-rays and/or scans to assess all disease sites are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday) Exclusion Criteria: * Patients currently receiving active therapy for other neoplastic disorders * Known parenchymal brain metastasis * Active or symptomatic viral hepatitis or chronic liver disease * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of \< 45 % at baseline, if done * Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy * Administration of an investigational therapeutic within 30 days of cycle 1, day 1 * Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent * Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible * Any condition which, in the opinion of the investigator, would preclude participation in this trial
References
Publications (0)
Data not yet available
No reference posted for this study.