A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC)

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma.

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

Details

• Lead Sponsor: Rambam Health Care Campus

Criteria

Inclusion Criteria:

• Ages eligible for this study are 18 years and older.

• Histological or cytological diagnosis of urothelial carcinoma. Mixed histologies are permitted as long as transitional cell carcinoma is the major component (i.e. > 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas are not permitted.

• Patients with transitional cell carcinomas of the renal pelvis and ureter are permitted.

• Patients must have metastatic or locally advanced unresectable disease.

• Patients must have received one and only one prior chemotherapeutic regimen which included platinum (at least one cycle) for metastatic/recurrent disease. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if the patient progressed within 12 months of the last dose.

• Patients with disease progression more than 12 months following platinum based chemotherapy can be included (rather than platinum re-challenge), according to the investigator's judgment.

• ECOG performance status ≤ 2

• Estimated life expectancy of > 12 weeks.

• Patients must have measurable disease according to RECIST1.1 criteria.

• If female of childbearing potential, pregnancy test is negative within 8 days priors to first dose of study drug.

• If fertile, patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study.

• Adequate organ function; Absolute neutrophil count ≥1.5 x 109/L. Platelet count ≥ 100 x109/L. Hemoglobin ≥ 9 g/dL. Total bilirubin ≤1.0x upper limit of normal. AST/SGOT and/or ALT/SGPT ≤ 2.5x upper limit of normal. Calculated creatinine clearance > 40 ml/min (creatinine clearance will be calculated according to CKD-EPI formula: http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr).(27)

• Able to give informed consent.

Exclusion Criteria:

• Prior taxane therapy.

• Pregnant or lactating females

• Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted if both known lesions and medications e.g. steroids for that indication are stable).

• History of serious or concurrent illness that might be aggravated by study treatment.

• Known human immunodeficiency virus (HIV) infection or active hepatitis B/C.

• History of class II-IV congestive heart failure.

• Significant renal impairment.

• Uncontrolled hematuria.

• History of severe hypersensitivity reaction (≥grade 3) to docetaxel.

• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.

• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix).

• Other malignancies except adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason < 7 PSA < 10ng/ml) or any other tumor within 2 years prior to enrollment.

• Other investigational therapy or radiation therapy within 30 days before registration.

• Patients not willing to employ adequate contraception for the duration of the study.