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

What Was Tested

In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had 1 arm (groups): Investigational Treatment (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Subsequent vitamin B12 injections may be given the same day as pemetrexed.

Alkaline phosphatase may be any value for patients with bone metastases.

Who Took Part

The registry lists 49 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically documented adenocarcinoma of the prostate. Clinically refractory or resistant to hormone therapy as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist). One prior taxane based chemotherapy regimen for HRPC. Documented progression of disease after one taxane based prior chemotherapy regimen for HRPC. Progression is defined as at least one of the following:. Progression of measurable disease as defined by RECIST.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: intravenous radio-isotopes therapy must be completed at least 6 weeks prior to registration; no brain metastasis that are untreated and/or not controlled and/or still requiring corticosteroids; no history of uncontrolled psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-02 with completion listed for 2009-03.

It ran at 15 sites in United States (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Best Overall PSA Response (time frame: Start of treatment until disease progression/recurrence (for life)).

It also tracked 7 secondary outcomes, for example Overall Survival, OBJECTIVE Overall Response Rate, Safety and Tolerability, RFC1 G80A Genotype, Time to Progression and Time to Prostate-Specific Antigen (PSA)/Serological Progression.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 49 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.