First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

• Status: Terminated
• Trial end date: 2018-04-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matthew Galsky
• Collaborators: Hoosier Cancer Research Network; Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Everolimus; Paclitaxel; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.