A Phase II study of Paclitaxel, and Vinorelbine (Pacl-Vin) in Hormone-refractory metastatic prostate cancer: Double Tubulin Targeting

Phase 2

Completed

• Conditions: Metastatic Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12605000316606
• Lead Sponsor: Bristol Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Hormone-refractory prostate cancer with metastases documented by bone scan and/or CT scan, with rising PSA and/or progressive metastatic disease with serum testosterone < 3.5 nmol/L. - Patients who have not had bilateral orchidectomy should continue therapy with a Luteinizing hormone-releasing hormone analogue. Antiandrogens should be ceased at least 28 days prior to study entry. - Adequate bone marrow function: absolute neutrophil count (ANC) at least 1.5 X 109/L and platelets at least 100 X 109/L. - Adequate renal function: serum creatinine less than or equal to 200µmol/L. - Adequate liver function: bilirubin less than or equal to 20µmol/L and AST/ALT less than or equal to 5 X upper limit of normal. - ECOG performance status 0-2. - Not more than one previous line of chemotherapy (prior exposure to vinorelbine and/or taxanes not allowable).

Exclusion Criteria

Prior radiotherapy within 21 days - Prior radioactive strontium within 42 days. - Concurrent treatment with other investigational agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA response[Measured at week 6 and week 10.]

Secondary Outcome Measures

Name	Time	Method
Overall survival[From day 1 until day of progression or death];Progression free survival[From day 1 until day of progression or death];Toxicity[Every 3 weeks];Quality of life[Every 3 weeks.]