PURPOSE: A phase I/II trial of @entity1205 , @entity900 , @entity1487 ( @entity1487 ), and leucovorin (TPFL5) induction chemotherapy for @entity1 with locally advanced @entity213 ( @entity213 ). @entity1 AND METHODS: Twenty-three previously untreated @entity1 with stage III or IV @entity213 and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophylactic antibiotics, and @entity1261 ( @entity1261 ). @entity1205 dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen @entity1 were treated with three cycles of TPFL5 at MTD. @entity1 who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. @entity137 and clinical and pathologic response to TPFL5 were assessed. RESULTS: Twenty-three @entity1 received a total of 69 cycles of TPFL5. The MTD was determined to be @entity1205 60 mg/m2. Dose-limiting @entity137 (DLT) was @entity1398 . Additional significant @entity137 at MTD were @entity390 , @entity33 , @entity294 , @entity1897 , and @entity1372 -wasting @entity8 . The overall response rate to TPFL5 was 100%, which included 14 of 23 (61%) clinical CRs and nine of 23 (39%) clinical PRs. Primary-site clinical and pathologic CR rates were 19 of 22 (86%) CRs and 20 of 22 (91%) CRs, respectively. Eight @entity1 had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for @entity41 . CONCLUSION: TPFL5 is a tolerable induction regimen in @entity1 with good performance status. The DLT is @entity1398 with significant @entity33 , @entity294 , @entity1897 , and @entity1372 -wasting @entity8 . The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials.

Induction chemotherapy with @entity1205 , XXXX , @entity1487 , and leucovorin for @entity213 : a phase I/II trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity8 :: ('MESH:D007674', 'Disease') :: ['nephropathy'] @entity137 :: ('MESH:D064420', 'Disease') :: ['Toxicity', 'toxicities', 'toxicity'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity1261 :: ('1440', 'Gene') :: ['granulocyte colony-stimulating factor', 'G-CSF'] @entity41 :: ('MESH:D018365', 'Disease') :: ['residual tumor'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity33 :: ('MESH:D052016', 'Disease') :: ['mucositis'] @entity1372 :: ('MESH:D012964', 'Chemical') :: ['sodium'] @entity1897 :: ('MESH:D010523', 'Disease') :: ['peripheral neuropathy'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil', '5-FU'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['Docetaxel', 'docetaxel'] @entity213 :: ('MESH:C535575', 'Disease') :: ['squamous cell carcinoma of the head and neck', 'SCCHN']
@entity900 :: (MESH:D002945,Chemical) :: ['cisplatin']
