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

NCT01600339 | Completed Phase 2 DMC

• 1 other identifier: ISGUOG1101.CTIL
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  The primary end point is objective response rate (ORR): CR+ PR, assessed according to response evaluation criteria in solid tumors (RECIST 1.1) guidelines.

  up to 2 years

Secondary Outcomes (7)

• Clinical benefit

  up to 2 years

• Duration of response

  up to 2 years

• Disease control rate

  up to 2 years

• PFS

  up to 2 years

• Overall Survival

  up to 2 years

Study Arms (1)

CABAZITAXEL

EXPERIMENTAL

cabazitaxel at a starting dose of 25 mg/m

Drug: CABAZITAXEL

Interventions

CABAZITAXEL DRUG

The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support.

CABAZITAXEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (2)

Rambam MC

Haifa, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Avivit - Pe'er, Dr.

  Rambam MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

IL (2)