Tag Archives: refractory colorectal cancer

FDA Approves Regorafenib for Metastatic CRC

  The FDA today approved the use of the drug regorafenib (brand name Stivarga) for patients whose metastatic colorectal cancer has progressed despite all currently approved treatment regimens. This is the second new drug approved by the FDA recently after a drought of 5 years in approving new treatments for metastatic colorectal cancer (mCRC). Regorafenib was placed into the  FDA’s “fast-track” approval process after the international, multicenter Phase III CORRECT trial  showed improved survival (from 5 to 6.4 months) in all mCRC patients, including those having both non-mutated and mutated KRAS types.

Disappointing Results for Perifosine

Perifosine was no better than a placebo in improving survival time for people with late-stage colorectal cancer according to a news release from Keryx Biopharmaceuticals. Despite success in a smaller Phase II clinical trial, the X-PECT Phase III trial failed to meet its primary objective — longer survival time. X-PECT randomized 468 patients to receive either: Xeloda® (capecitabine) plus perifosine, or Xeloda plus a placebo Although final details were not provided, the perifosine group did not live longer than the patients who got a dummy pill. Patients in the trial had refractory colorectal cancer, tumors that had already gotten worse on at least two standard chemotherapy regimens. Had perifosine helped

X-PECT Trial is Fully Enrolled

The X-PECT phase III clinical trial has finished recruiting over 430 patients, evaluating perifosine treatment for patients with advanced colorectal cancer who have exhausted standard treatments. The trial compares the effectiveness of adding perifosine to Xeloda® (capecitabine). Led by Johanna Bendell, M.D., from the Sarah Cannon Research Institute in Nashville, TN, the trial is being conducted at 65 sites in the United States.

Afinitor Combined with Avastin Promises Help for Advanced Colorectal Cancer

Some colorectal cancer patients whose tumors had gotten worse on all standard treatments benefited from a combination of Afinitor® (everolimus) and Avastin® (bevacizumab) during a small trial reported at the 2010 ASCO Annual meeting in Chicago. While no tumors got smaller on the treatment, about half of patients in the Phase II trial had their cancer remain stable for six months or more.  Three patients have had stable disease for more than a year. Seven out of ten patients in the trial had at least one serious side effect.  The most common was hypertension, but there were several bowel abscesses or fistulas and one case of bowel perforation.  There was

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