Protocol: ECOG – EA8192
Please Note: Below is partial eligibility, for full eligibility requirements, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 and/or (810)762-8038. Thank you!
- Patient must be ≥18 years of age.
- Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 12 weeks (84 days) prior to registration/randomization with one of the following:
- • Upper urinary tract mass on cross-sectional imaging or
- Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. NOTE: Biopsy is SOC and required for enrollment to study. This is vital for best practice.
- Patients must not have any component of small cell/neuroendocrine carcinoma. Other variant histologic types are permitted provided the predominant (≥ 50%) subtype is urothelial carcinoma.
- Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (≥1.5 cm short axis) on imaging required within 28 days prior to registration. (Non-regional findings ≥1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on PET or other imaging or other criteria can be eligible based on investigator discretion). NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scans to evaluate for bone metastasis at the discretion of local provider.
- Non-urothelial cancer malignancy history: Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g., ≤Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising PSA and no plan to treat.. NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients in whom concomitant or prior bladder/urethra
predominant (≥50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed.
- Urothelial cancer malignancy history: Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:
• T0, Ta or Tis at any time
• T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy [e.g., radical surgery, TURBT, radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)]. Prior immune checkpoint inhibitor is not allowed. Patient with history of≥pT4b, N+, and/or M1 is not eligible. NOTE: Patients in whom concomitant or prior bladder/urethra predominant (≥ 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or CIS (< cT1 N0) are eligible regardless of time elapsed.
- Patient must not have received prior radiation therapy to ≥ 25% of the bone marrow for other diseases.
- Patient must not have received prior systemic anthracycline therapy. NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible.
- Patient must not have had a major surgical procedure within 28 days prior to registration/randomization. NOTE: Cystoscopy/ureteroscopy, stent placement or nephrostomy tube is not considered major surgery.
10. Patient must have life expectancy of ≥ 12 weeks.
11. Patient must have a body weight of > 30 kg.
12. Patient must have ECOG Performance Status 0-2.