Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256308
First received: November 17, 2005
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: Oxaliplatin
Procedure: Radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Assess the frequency and severity of toxicities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the 2 year locoregional control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxaliplatin
    70mg/m2 IV over 120 min once a week during radiation
    Other Name: Eloxatin
    Procedure: Radiation
    200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256308

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Ignatius Ou, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Sai-Hong Ignatius Ou, MD, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00256308     History of Changes
Other Study ID Numbers: UCI 04-40
Study First Received: November 17, 2005
Last Updated: May 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Head and Neck Cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014