TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Sponsor

Achieve Life Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00077688

Collaborator

(none)

Enrollment

Locations

Duration (Months)

14.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Neoplasms Ureteral Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell	Drug: TOCOSOL Paclitaxel	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2003

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Objective response rate []

Secondary Outcome Measures

Time to treatment failure []
Time to progression []
Progression free survival []
Overall survival at 2 years []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center/Greenbaum Cancer Center	Baltimore	Maryland	United States	21201
2	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
3	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington	United States	98109