Status:
COMPLETED
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
Lead Sponsor:
Achieve Life Sciences
Conditions:
Bladder Neoplasms
Ureteral Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00077688
Start Date
November 1 2003
End Date
September 1 2007
Last Update
June 4 2009
Active Locations (3)
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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