Clinical trial NCT00077688: TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Neoplasms
Ureteral Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Time to treatment failure
measure: Time to progression
measure: Progression free survival
measure: Overall survival at 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center/Greenbaum Cancer Center
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Seattle
country: United States
facility: University of Washington/Seattle Cancer Care Alliance
state: Washington
Study officials:
References: