Phase II Trial of Abraxane in Front Line Therapy of Hormone Refractory Metastatic Prostate Cancer

NCT00284752 | Completed Phase 2

• 1 other identifier: TK001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Prostate; Cancer; Metastatic

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of Abraxane in first line chemotherapy of patients with

  August 2008

• hormone refractory metastatic prostate cancer, based on prostate specific antigen (PSA) response

  August 2008

Secondary Outcomes (2)

• Evaluate the effect of Abraxane on,Time to PSA progression, Measurable tumor response rate (if measureable disease at baseline), Overall survival

  August 2008

• Evaluate the toxicity of Abraxane in this group of patients.

  August 2008

Study Arms (1)

ABI-007

EXPERIMENTAL

Drug: Abraxane

Interventions

Abraxane DRUG

This is a Phase II single-arm study for first-line chemotherapy of patients with hormone refractory metastatic prostate cancer. Eligible patients will be chemotherapy naive and will receive weekly Abraxane 100mg/m2 IV over 30 minutes. These will be 4-week cycles with patients receiving Abraxane 100 mg/m2 weekly for 3 weeks and one week off for rest. Patients will continue on therapy until disease or PSA

ABI-007

Eligibility Criteria

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

You may qualify if:

• 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
• No prior chemotherapy
• 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).
• PSA progression is defined as rising PSA.

You may not qualify if:

• Active malignancy other than non-melanoma skin cancer within 5 years of enrollment.
• Significant active medical illness which in the opinion of the investigator will preclude treatment.
• Brain metastasis, any non-bone metastasis except lymph node metastasis

Sponsors & Collaborators

• Kaiser Permanente: lead
• Celgene Corporation: collaborator

Study Sites (1)

Kaiser Permanente

Vallejo, California, 94589, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Tatjana Kolevska, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: February 1, 2006
• Study Start: August 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2011
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (1)