Corel Medical Series: Cancer/Corel Medical Series: Cancer.iso/pc/program/p04.dxr/00035_SRC.p04.C.20.txt

Text File | 1997-01-28 | 1.6 KB | 17 lines

• Phase I About 20 human patients are treated with the same drug. There is no assurance or certainty that a
  significant tumor response will occur, although, again, every single anticancer drug now useful in therapy was
  initially a Phase I agent.
      Patients selected for these trials are almost always in cancer research centers and have already received all
  known effective anticancer therapy. After the proposed treatment is explained to them, they may volunteer to
  receive the new treatment. There is, therefore, no moral objection to giving this new treatment. Since there is
  "nothing to lose," it is hoped that a specific new agent may in fact prove effective.
      This phase is completed when no unusual problems or toxic effects have been found and the dose necessary
  to produce a biologic effect has been determined. The study can then move to the next phase.
• Phase II Ten to 20 patients are treated, each with various types of tumors known to be responsive to
  chemotherapy . These might include lymphomas, breast cancer or colon cancer. Since these tumor types are
  known to be responsive, the patients will be those who have already received all standard forms of therapy
  that seem reasonable. The use of a Phase II trial does not deprive anyone of any therapy known to be effective.
  If a significant number of patients with each type of tumor respond to the therapy, the trial moves to the next
  level.
• Phase III In this phase the new therapy is compared with standard treatment to see if there is an improvement
  in the response or if the same response rate is achieved but with less-toxic side effects.