Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium

NCT00034177 | Completed Phase 2

• 1 other identifier: SON-8184-1065
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.

Conditions

Urologic Neoplasms

Keywords

Locally Advanced, Metastatic, or Recurrent Transitional Cell Carcinoma of the Urothelium

Outcome Measures

Primary Outcomes (1)

• Objective response rate; time to disease progression; duration of response; survival; toxicities

  After all patients completed treatment

Secondary Outcomes (1)

• To determine time to disease progression

  After all patients have completed treatment

Interventions

S-8184 Paclitaxel Injectable Emulsion DRUG

Experimental Arm: TOCOSOL Paclitaxel DRUG

Doses of 80, 100 and 120mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of transitional cell carcinoma of the urothelium including renal pelvis, ureter, bladder, or urethra
• Locally advanced with lymph node disease(unresectable T3-4, N+, M0); metastatic (T any, N any, MI); or locally recurrent disease following initial definitive therapy
• One and only one prior systemic cytotoxic chemotherapy regimen (note that intravesical treatments are not included in the definition of systemic cytotoxic chemotherapy)
• Failure of first line systemic chemotherapy with a platinum-containing combination regimen consisting of MVAC or cisplatin/gemcitabine with cisplatin dosed at 60 mg/m2 or higher per cycle
• Adult (18 years of age or older) patients
• Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
• Serum creatinine less than 2.0 mg/dL
• Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
• ECOG performance status of 0 - 2
• Bidimensional measurable disease
• Patients who have signed an IRB / Ethics Committee approved informed consent
• Life expectancy at least 12 weeks
• Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
• Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

You may not qualify if:

• Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
• Patients with intracranial metastases
• Females who are pregnant or lactating
• Patients with peripheral neuropathy NCI-CTC grade 2 or greater
• Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
• Patients who have had an investigational agent within 4 weeks of study entry
• Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes

Sponsors & Collaborators

• Achieve Life Sciences: lead

MeSH Terms

Conditions

Urologic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2002
• First Posted: April 25, 2002
• Study Start: April 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 4, 2009

Record last verified: 2009-06