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Platinum-based Chemotherapy

Treatment (chemotherapy and enzyme inhibitor) for Prostate Cancer

Phase 2

Waitlist Available

Led By Jacek Pinski

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after every 2 courses, and then every 6 months after off-study (recist) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (psa) until progression

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving oxaliplatin together with pemetrexed disodium may kill more tumor cells.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recist evaluation: baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. psa evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recist evaluation: baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. psa evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and recist evaluation: baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. psa evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Response

Secondary study objectives

Number of Participants With Serious Adverse Events (SAEs)

Time to Disease Progression and Overall Survival

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy and enzyme inhibitor)Experimental Treatment6 Interventions

Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

FDA approved

Pemetrexed

FDA approved

reverse transcriptase-polymerase chain reaction

2010

Completed Phase 2

~11710