Status:
TERMINATED
First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma
Lead Sponsor:
Matthew Galsky
Collaborating Sponsors:
Hoosier Cancer Research Network
Novartis Pharmaceuticals
Conditions:
Transitional Cell Carcinoma
Bladder Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.
Detailed Description
OUTLINE: This is a multi-center study Patients will be enrolled into one of two parallel cohorts: * Cohort 1: impaired renal function AND poor performance status (cycle length = 28 days). Everolimus...
Eligibility Criteria
Inclusion
- Histological or cytological proof of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but still requires a component of TCC.
- Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
- Must be ineligible for cisplatin, based on the following, within 30 days prior to registration for protocol therapy.
- Prior radiation therapy is allowed to \< 25% of the bone marrow.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age \> 18 years at the time of consent.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to prior to registration for protocol therapy.
- Females must not be breastfeeding.
Exclusion
- No prior chemotherapy for metastatic disease. Prior chemotherapy in the neoadjuvant/adjuvant setting is allowed if completed at least 12 months prior to registration for protocol therapy.
- No active CNS metastases or leptomeningeal metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
- No prior malignancy is allowed except for adequately treated basal cell or adequately treated squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 7 prostate cancers (treated definitively with no evidence of PSA progression), or other cancer for which the patient has been disease-free for at least 5 years.
- No treatment with any anticancer therapy or investigational agent within 30 days prior to registration for protocol therapy.
- No known hypersensitivity to any protocol treatment.
- No prior treatment with mTOR inhibitor (sirolimus, temsirolimus, everolimus).
- No history of immunization with attenuated live vaccines within one week prior to registration for protocol therapy or during study period.
- No severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air.
- No uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN.
- No active (acute or chronic) or uncontrolled severe infections.
- No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
- No known history of HIV seropositivity.
- No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
- No active, bleeding diathesis.
- No history of major surgery (defined as requiring general anesthesia) or significant traumatic injury within 30 days prior to registration for protocol therapy.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01215136
Start Date
December 1 2010
End Date
April 24 2018
Last Update
November 24 2023
Active Locations (11)
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1
University of Alabama Hematology Oncology Clinic at Medical West
Birmingham, Alabama, United States, 35294
2
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
3
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
4
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202