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In locoregionally impaired head and neck patients, determine the maximum tolerated dose, the recommended phase II dose, dose limiting toxicity, and safety of ABT-888 with carboplatin and paclitaxel induction chemotherapy. In LAHNC, compare the magnitude of tumor shrinkage following two cycles of induction chemotherapy with and without ABT-888. PHASE I: Patients receive veliparib orally twice a day on days 1-7, pacing intravenously over 60 minutes on days 1, 8, and 15, with carboplatin IV exceeding 30 minutes on day 1. PHASE II: Patients are randomly assigned to one of two treatment arms. ARM I: Patients are in Phase I, with veliparib, paclitaxel, and carboplatin. In the absence of disease progression or unacceptable toxicity, treatment repeats every 3 weeks for two courses. Patients begin concomitant chemoradiotherapy within ten days after completion of course 2. ARM II: Patients are given placebo BID from days 1-7. Patients in Phase I also receive paclitaxel and carboplatin. Patients begin concomitant chemoradiotherapy within ten days after the completion of course 2. Patients are randomized to one of two regimens of concomitant chemoradiotherapy based on the guidelines of the institution where they are being treated. CONCOMITANT CHEMORADIOTHERAPY: Patients are referred to 1 of two regimens of concomitant chemoradiotherapy. Patients receive cisplatin IV on days 1 and 22 and do radiation therapy for six weeks per week. Patients receive hydroxyurea PO every 12 hours on days 1-5, fluorouracil IV over 120 hours on day 1-5, paclitaxel IV over 120 hours, on day 1-5, and bone graftaxil IV over 120 hours, and radiation therapy BID is required on days 1-5.
Source link: https://clinicaltrials.gov/ct2/show/NCT01711541
Although most of the time cytotoxics were fluorouracil and cisplatin, chemotherapy also involved the use of cytotoxics, dosage, and number of cycles, although most of the time, cytotoxics were fluorouracil and cisplatin. NCRT with weekly carboplatin and paclitaxel increases survival, despite declining postoperative mortality, according to Dutch colleagues recently. Of note, the majority of tumors in this trial came from the lower third of the esophagus and esogastric junction, and they generally correlate with less postoperative morbidity than those in upper third tumors. In addition, the lung volume saved from radiation was higher in junctional tumors than in upper third cancers, a critical point in the development of radiation-induced pneumonitis and subsequent postoperative mortality. This is difficult to determine whether this taxane-based chemotherapy is effective, as it did not make more than fluorouracil-based regimen in non-operable patients, and as NCRT with taxanes makes radiation-induced pneumonitis more likely. In the case of definitive chemoradiotherapy, the Dutch NCRT regimen's most beneficial outcome may be that it does not include cisplatin, a drug that has been linked to the occurrence of more sudden deaths than a non-cisplatin-based regimen such as the FOLFOX combo. In large random controlled trials presenting level-1 data, the present trial provides the unique opportunity to compare two therapeutic strategies that have already been shown to be effective.
Source link: https://clinicaltrials.gov/ct2/show/NCT02359968
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