PATIENTS WITH METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE TRANSITIONAL CELL CARCINOMA OF THE UROTHELIUM
Conditions
Interventions
Product Name: TOCOSOL® Paclitaxel
Product Code: S-8184
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Paclitaxel
CAS Number: 33069-63-4
Current Sponsor code: S-8184
Concentration unit
Sponsors
SONUS Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Histologic diagnosis of TCC of the urothelium including bladder, renal pelvis, ureter, or urethra. Patients with mixed tumors (i.e. tumors containing elements of squamous cell or adenocarcinoma in addition to transitional cell carcinoma) are eligible, but patients with pure non-transitional cell carcinoma are not. b)Stage IV disease, i.e., metastatic (any T any N M1) or locally advanced (T4b N0 M0 or any T N1-3 M0) disease deemed incurable by surgical resection c)One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease. (Intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy.) Prior chemotherapy should have included a minimum of two cycles of standard dose MVAC (methotrexate, vinblastine, Adriamycin and cisplatin) or cis/carboplatin and gemcitabine. Other prior chemotherapy regimens of presumed comparable efficacy and dose intensity may be acceptable if approved by the Sonus Medical Director or his designee. d)Adequate hematologic function (ANC > 1500 cells/mm3 and platelet count >100,000/mm3) e)Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a)Prior taxane-containing chemotherapy including Taxol (paclitaxel) or generic equivalent, or Taxotere (docetaxel) b)Peripheral neuropathy NCI-CTC grade 2 or greater c)Wide-field radiation (radiation to more than 20% of the marrow bearing skeleton), cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug d)An investigational agent within 4 weeks of first dose of study drug e)Concurrent therapy with substrates known to produce clinically significant inhibition of the cytochrome P450 isoenzymes CYP2C8 or CYP3A4, e.g., dexamethasone is NOT an excluded concomitant medication. f)Patients who are pregnant or lactating g)A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC h)Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC. (Patients with these findings in addition to a measurable target lesion are eligible.) i)Brain metastasis j)Active bowel obstruction k)Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol. (Any ambiguous clinical circumstances must be reviewed and approved by a Sonus Medical Director). l) Concurrent therapy with warfarin or other coumarin derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the confirmed objective response rate (ORR), defined by RECIST criteria as the percentage of patients who achieve a complete response (CR) or a partial response (PR), in patients with previously treated TCC of the urothelium following administration of TOCOSOL® Paclitaxel, 100 mg/m2/week over 15 minutes.;Secondary Objective: • To estimate time to treatment failure (TTF), time to progression (TTP), progression free survival (PFS), and 2-year overall survival (2-yr OS) in this population • To determine if this dosing regimen (dose and schedule) of TOCOSOL® Paclitaxel is well tolerated in this patient population • at selected study sites, to investigate whether there is accumulation of vitamin E in the serum, i.e., progressive rise in steady state serum vitamin E concentration after successive doses • To obtain additional data regarding the utility of histamine blockers and corticosteroids in ameliorating infusion reactions ;Primary end point(s): *Objective response rate *Median time to treatment failure *Median time to disease progression *Median progression-free survival and overall survival rate at 2 years will be assessed for all eligible patients and descriptively reported with 95% confidence intervals | — |
Countries
Spain, United Kingdom
Outcome results
None listed