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Pemetrexed as Second-Line Therapy in Treating Patients With Hormone Refractory Prostate Cancer

NCT00216099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-07-29

Study results available
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Summary

Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting.

This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.

Conditions

Interventions

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle

DIETARY_SUPPLEMENT

Folic Acid

All participants received oral Folic Acid 350-100ug once per day for 7 days preceding the first pemetrexed dose and continuing throughout the study and and for 21 days after the last dose of pemetrexed.

DIETARY_SUPPLEMENT

Vitamin B12

All patients received vitamin B12 1000ug intramuscular injection the week preceding the first pemetrexed dose and received additional 1000ug intramuscular injections every three cycles thereafter on the same day of pemetrexed administration.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Christopher Sweeney, MBBS

    lead OTHER

Principal Investigators

  • Christopher Sweeney, M.B.B.S. · Hoosier Oncology Group, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216099 on ClinicalTrials.gov