Devita, Hellman, and Rosenberg's Cancer

LWBK1006-16 LWW-Govindan-Review December 12, 2011 18:55

184 DeVita, Hellman, and Rosenberg’s CANCER: Principles and Practice of Oncology Review

Question 16.4. Traditional Phase I trials are designed to determine a dose that is appro-

priate for use in Phase II trials. Which of the following statements on

traditional Phase I trials are NOT true?

A. Some patients may receive subtherapeutic doses of the treatment

drug.

B. A prolonged period of time may be required to complete the trial.

C. Dose escalation in the individual patient is allowed.

D. Information regarding cumulative toxicity from the study drug may

be limited.

Question 16.5. A drug, device, or other treatment may be considered for Phase II testing

when:

A. The maximum tolerable dose is known but there is genuine doubt

about efficacy, and patients with the condition of interest and a likely

favorable outcome can be recruited as study participants.

B. A standard treatment exists for comparison.

C. Accrual is rapid enough to allow recruitment of 20 to 30 patients.

D. An appropriate control group can be recruited at the same time as

the experimental group.

Question 16.6. All of the following statements regarding Phase II trial are correct,

EXCEPT:

A. Phase II trials are traditionally performed in patients with the same

tumor type.

B. Two-stage designs allow for early elimination of ineffective drugs.

C. Patient eligibility should not be restricted by biomarker testing.

D. Phase II trials can help develop predictive biomarker assays for the

study drug.

Question 16.7. Phase II trials of a single agent are designed to determine whether the

experimental drug has any antitumor activity against a given type of

tumor, and the antitumor effect is often measured as an objective response

based on tumor shrinkage. However, such a trial is not appropriate for

the question of patient welfare because:

A. The welfare of patients with cancer is often measured by survival or

symptom control, but there is no necessary relationship between such

beneficial end points and tumor response.

B. Survival is inherently a comparative end point that should be assessed

in a prognostically comparable set of patients. Unfortunately, Phase

II trials are often conducted without concurrent controls.

C. Comparing the survival times of responders and nonresponders is

not a valid means of showing a treatment is beneficial to patients

because responders may have more favorable prognostic factors than

nonresponders.

D. All of the above.