Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry SON-8184-1073 NCT00077688

Trial Description

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

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sonus Pharmaceuticals

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00077688
Information obtained from ClinicalTrials.gov on May 27, 2008