Complete Response Rate Achieved 1 Month After Concurrent Chemotherapy and Radiation Treatment

ZD1839 500mg by Mouth (po) Daily

Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone. Induction chemotherapy: ZD 1839 (250mg/day), two cycles of Paclitaxel (100mg/m2 days 1, 8, 15), Carboplatin (AUC 6, day 1). Concurrent chemotherapy and radiation treatment began 1-2 weeks after induction chemotherapy: 4-5 14 day cycles (5 days of 500 mg of hydroxyurea orally every 12 h, 600mg/m2/d of continuous infusion fluorouracil, and 1.5Gy of radiation twice per day followed by 9 days without therapy.

Analysis denominator · Participants

1. ci Lower Limit

   0.77

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   0.95

   group Ids

   1. OG000

   non Inferiority Comment

   The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.

   non Inferiority Type

   NON_INFERIORITY

   p Value

   < 0.01

   p Value Comment

   Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65

   param Type

   proportion

   param Value

   0.88

   statistical Method

   Binomial test for a proportion