Carcinoma, Transitional Cell Clinical Trial
Official title:
A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium
Verified date | June 2009 |
Source | OncoGenex Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
Status | Completed |
Enrollment | 44 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra - Stage IV disease - One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease - Adequate hematologic function (ANC >/= 1500 cells/mm3 & platelet count >/= 100,000/mm3) - Serum creatinine </= 2.0 mg/dL - Total bilirubin </= 1.5 mg/dL - SGOT & SGPT </= 3 times upper limit of institutional normal values - PT (INR) & PTT within institutional lab normal range - Karnofsky performance status of 60-100% - At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria - Signed IRB/EC approved Informed Consent - Life expectancy of at least 12 weeks - 18 years of age or older - Fully recovered from any previous surgery - Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females) - Agree not to take vitamin E supplementation while receiving study medication - Willing to participate in requested follow-up evaluations - Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug Exclusion Criteria: - Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel) - Peripheral neuropathy NCI-CTC grade 2 or greater - Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug - An investigational agent within 4 weeks of first dose of study drug - Concurrent anticonvulsants known to induce P450 isoenzymes - Patients who are pregnant or lactating - 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 - Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC - Brain metastasis - Active bowel obstruction - Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center/Greenbaum Cancer Center | Baltimore | Maryland |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University of Washington/Seattle Cancer Care Alliance | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
OncoGenex Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate | |||
Secondary | Time to treatment failure | |||
Secondary | Time to progression | |||
Secondary | Progression free survival | |||
Secondary | Overall survival at 2 years |
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