Phase 2
Completed N=21
Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer
Source: ClinicalTrials.gov NCT01938573 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Patients With Dose Limiting Toxicity — 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Dose Limiting Toxicity |
— | — |
| PRIMARY Percent of Patients With Pathologic Complete Response (Phase II) |
4 | — |
| SECONDARY Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II) |
45 | — |
Eligibility Criteria
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 = = 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) = = 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
Data sourced from ClinicalTrials.gov (NCT01938573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.