Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments oxaliplatin, radiation
Phase phase 2
Sponsor University of California, Irvine
Start date April 2005
End date December 2010
Trial size 20 participants
Trial identifier NCT00256308, UCI 04-40

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 5FU and radiation in the treatment of rectal cancer. A total of 40 operable subjects were entered onto the study. Radiotherapy was delivered with A three-field technique to a dose of 50 Gy (total dose) over 5 weeks with a concomitant boost approach. Two cycles of chemotherapy were given synchronously on weeks 1 and 5, with Oxaliplatin 130 mg/m2 in day 1 followed by continuous infusion of fluorouracil 350 mg/mg2 and L-folinic acid 100mg/m2 for 5 days. Surgery was planned 5 weeks later. All subjects completed treatment without modification except one who experience grade 3-4 toxicity. Grade 3 toxicity was seen in seven subjects. Surgery was performed in all subjects after a mean interval time of 5 weeks. An objective clinical response was seen in 30 subjects (75%). Sphincter-saving surgery was possible in 26 subjects. No postoperative deaths occurred. In four subjects (10%), a reoperation was necessary (anastomotic fistula, n=2; pelvic abscess, n=2). In six cases the operative specimen was sterilized (15%), and in 12 cases (30%), only few residual cells were detected. Such 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, 5FU, 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 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 tracheosphageal 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Assess the frequency and severity of toxicities
time frame: 2 years

Secondary Outcomes

Measure
Evaluate the 2 year locoregional control rate
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. The tumor must be considered to be resectable by one of the two Otolaryngology surgeons (Dr. Armstrong or Dr. Terry Shibuya). - Primary tumor sites include: oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis subglottis). Nasopharynx primary will be excluded. - The resected tumor must have one or more of the following high risk features: histologic extracapsular nodal extension involvement of ≥ 2 regional lymph nodes, mucosal margin of resection with invasive cancer (limited to microscopic detection only), tumor with perineural invasion, tumor with lymphovascular invasion, oral cavity and oropharynx carcinomas with positive lymph nodes metastasis at level IV or V. - Radiation must begin within 28 to 56 days after surgical resection. - Subjects must not have distant metastatic disease (M1). - All subjects must be 18 years of age or older. - Subjects must have a Zubrod performance of 0-2. - Subjects must NOT have prior therapy with oxaliplatin. - Subjects with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.

Additional Information

Official title A Phase II Study of Adjuvant Chemoradiation With Weekly Oxaliplatin in Patients With High Risk Resected Squamous Cell Carcinoma of the Head and Neck Region
Principal investigator Ignatius Ou, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University of California, Irvine.