Phase II Trial Underway of Velcade for Advanced Colorectal Cancer

Millennium Pharmaceuticals Inc. announced the initiation of a Phase II clinical trial of the proteasome inhibitor Velcade (bortezomib) in patients with advanced colorectal cancer.

The randomized, open-label study, being conducted at 20 medical centers, will assess the response rates of patients with refractory metastatic colorectal cancer to treatment with Velcade alone or Velcade plus Camptosar (irinotecan hydrochloride injection).

Camptosar, a topoisomerase I inhibitor, is used in treatment of patients with colorectal cancer whose disease has recurred or progressed following chemotherapy.

The Velcade trial will enroll 175 patients with colorectal cancer whose disease has progressed following treatment with no more than two prior chemotherapeutic regimens.

"We have seen encouraging preclinical and early clinical results with bortezomib in solid tumors that have provided the scientific basis to initiate this Phase II study," said researcher David P. Ryan of Massachusetts General Hospital.

Researchers believe Velcade interferes with proteins that regulate cells' growth cycles, causing cancer cells to die.

Other Sources: Millennium Pharmaceuticals