Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer
Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Oxaliplatin-containing regimens have been safely and successfully used in combination with
concurrent radiation in treatment of solid tumors such as rectal and esophageal cancers. The
Lyon R0-04 phase II trial utilized the combination of Oxaliplatin, infusional 5-fluorouracil
(5-FU) and radiation in the treatment of rectal cancer. The trial showed a combined
preoperative chemoradiotherapy and Oxaliplatin-containing regimen is well tolerated with no
increase surgical toxicity. The good response rate observed warrants its use in further
clinical trials.
The combination of oxaliplatin, 5-FU, and radiation also have been used in a Phase I/II trial
in esophageal cancer. In this particular trial, eligibility included therapeutically naïve
esophageal cancer subjects with clinical disease stages II to IV. Initial doses and schedules
for cycle 1 consisted of Oxaliplatin 85 mg/m2 on days 1, 15, and 29; continuous infusion of
5-FU 180 mg/m2 for 24 hours for 35 days; and radiation therapy (RT) 1.8 Gy in 28 fractions
starting on day 8. At completion of cycle 1, eligible subjects could undergo an operation or
begin cycle 2 without RT. Postoperative subjects were eligible for cycle 2. Stage IV subjects
were allowed three cycles in the absence of disease progression. 38 subjects were treated (22
stage IV, 16 stage II-III). 38 eligible subjects received therapy: 22 non-invasively staged
as IV and 16 non-invasively staged as IV and 16 non-invasively staged as II and III. 36
subjects completed cycle 1, 29 subjects started cycle 2, and 24 subjects completed cycle 2.
The combined-modality therapy was well tolerated, but dose limiting toxicity (DLT) prevented
Oxaliplatin and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3
and two grade 4 clinical toxicities were noted in eight subjects. After cycle 1, 29 subjects
(81%) had no cancer in the esophageal mucosa. 13 subjects underwent an operation with intent
to resect the esophagus and 5 subjects (38%) exhibited pathologic complete responses. There
was no surgical mortality. Only 1 subject developed post-operative tracheoesphageal fistula.
The results of these trials described above indicated that combination of oxaliplatin and
radiation is safe and efficacious and dose not compromise surgical wound healing, repair and
clinical outcome.