Once we develop metastatic androgen-independent prostate cancer and experience disease progression after receiving docetaxel-based chemotherapy we have no approved treatment options. We have hit the proverbial wall!

In the process of attempting to develop additional treatments, ImClone Systems Inc. (NASDAQ: IMCL), announced the beginning of a Phase II clinical trial for men with advanced prostate cancer. Men with metastatic androgen-independent prostate cancer who have experienced disease progression during or within 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy will be enrolled in this trial.

This multi-center, randomized open-label Phase II single-arm trial will enroll 132 men. As with all Phase II trials, all subjects will receive treatment (no placebo). The overall goal of Phase II trials is to determine both efficacy and toxicity (safety) of the treatment being evaluated.

The treatments being evaluated are IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 is a fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody and IMC-1121B is its fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

In 2007, ImClone completed enrollment into two Phase I study of IMC-A12 which demonstrated favorable safety and pharmacokinetic profiles, as well as preliminary evidence of antitumor activity as a single agent.

In addition to this Phase II study, other Phase II studies were announced of IMC-A12 in adult and adolescent patients with soft tissue sarcoma, untreated advanced prostate, pancreatic, colorectal, liver, and head and neck cancers, as well as a series of Phase I/II studies in pediatric malignancies and another evaluating the combination of IMC-A12 and temsirolimus.

In April 2008, ImClone announced an agreement with the Food and Drug Administration on a Special Protocol Assessment for a Phase III study of IMC-1121B in women with metastatic breast cancer, which recently commenced.

Malecare’s clinical trial enrollment page,
Additional information about this trial may be found at the United States government web site: www.clinicaltrials.gov.

When considering any clinical trial discuss with your treating doctors your individual clinical situation. Remember that all trials can pose a risk, but it is only through trials can we hope to see progress in beating prostate cancer.

Joel T Nowak, MA, MSW