Phase 1 clinical trials have been key to the approval of drugs now approved and used internationally in the treatment of cancer. Some of the drugs initially tested in Phase I trials that are now considered standards of care in their respective diseases include:

  • CPT11 (Camptosar) and Zoledronic Acid (Zometa) - two of the first drugs tested in 1996 when the Cancer Therapy Development Program began. CPT11 was the first drug approved for advanced colorectal cancer in the past 40 years and Zometa is now used for patients with any type of cancer that has spread to the bone, in order to reduce fractures, needs for surgery, radiation or pain medication. All of these approvals were based on published international, multi-center trials.
  • Rituximab (Rituxan) and Cladribine (Leustatin) - two molecules widely used in the treatment of hematologic malignancies (certain leukemia's and lymphomas). These targeted therapies seek to deliver therapy directly to the cancer, avoiding the toxicity to the normal cells.
  • Biochemotherapy - the combination of conventional chemotherapy and medicines to stimulate the immune system has now become the standard of care for advanced melanoma as the result of several large pivotal trials.
  • Angiogenesis inhibitors - drugs that act by cutting off the blood supply to tumors to prevent their growth or spread have been undergoing testing in clinical trials. One such agent, SU5416, was the focus of an in-depth profile on 60 Minutes in 1999. A successor drug, SU11248, more broadly active and less toxic, has shown some exciting results in its early testing. Some patients with tumors long resistant to conventional chemotherapy are clinically improving and their tumors are shrinking.