Clinical trial · Interventional
Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer
NCT00284752CI-TRIAL-00008178completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy of Abraxane in first line chemotherapy of patients with hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ABI-007
- interventionNames
- Drug: Abraxane
Primary outcomes (2)
- measure
- Evaluate the efficacy of Abraxane in first line chemotherapy of patients with
- timeFrame
- August 2008
- measure
- hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response
- timeFrame
- August 2008
Secondary outcomes (2)
- measure
- Evaluate the effect of Abraxane on,Time to PSA progression, Measurable tumor response rate (if measureable disease at baseline), Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically or cytologically proven adenocarcinoma of the prostate metastatic to the bones or lymph nodes as documented by bone scan or CT scan with evidence of progression despite standard hormonal management (orchiectomy, GNRH agonist, or GNRH antagonist-hormone refractory). No major organ allowed 2. No prior chemotherapy 3. For patients who have been on anti-androgen therapy, patients must have progressive disease after anti-androgen withdrawal (6 weeks biclutamide or nilutamide, 4 weeks for flutamide). 4. PSA progression is defined as rising PSA. Exclusion Criteria: 1. Active malignancy other than non-melanoma skin cancer within 5 years of enrollment. 2. Significant active medical illness which in the opinion of the investigator will preclude treatment. 3. Brain metastasis, any non-bone metastasis except lymph node metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.