Hi --

We asked Barry's RO about the on-going Phase 2 erlotinib (Tarceva) trial at John Hopkins, since we know some of the participants and it had been offered to Barry at the beginning. This trial is different from the one your husband has been offered in that it is being used up-front in conjunction with conventional chemoradiation (cisplatin, IMRT). However the Phase 1 trial had established the tolerated doses. Our RO indicated that it did seem to be adding benefit to the treatment, but was cautious that of course it is a long way from final results being in. The main side-effects, which we had been told about, appear to be acne. (Barry was offered this trial but declined because he wanted to avoid using cisplatin).

However my point is that there is some existing information on dose/side-effect response for this drug, even though it was used in a different manner. You may wish to ask your husband's medical oncologist about how the dose John would receive compares to the doses being given in the Phase 2 combination therapy trials, as this may provide some information on expected toxicity and side effects.

Barry is in a bit of the same situation as John, he has been offered a HPV vaccine trial if his ongoing tests continue to show that his treatment, completed 9/28, was effective. It is also a Phase 1 trial to see if the vaccine will reduce recurrence rates in HPV+ HNC. However, not much data exists on dose and possible toxicity...so a bit of a gamble as well.

Gail
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Barry SCC right tonsil and BOT, 2 nodes, dx 6/21, Stage IV, HPV-16+, tonsillectomy, carboplatin 7X, tomo-therapy IMRT 33x, tx ended 9/28.