Adjuvant Chemoradiation With Weekly Oxaliplatin in Resected Head and Neck Cancer

NCT00256308 | Terminated Phase 2 Results DMC

• 2 other identifiers: UCI 04-402004-3999
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; oxaliplatin; resected squamous cell carcinoma; Eloxatin™

Outcome Measures

Primary Outcomes (1)

• Frequency and Severity of Toxicities

  Study was terminated by funding source for slow accrual. Upon termination notification, the IRB closure was submitted and all research procedures stopped, inclusive of completing any analysis of data collected.

  2 years

Secondary Outcomes (4)

• Locoregional Control Rate

  2 years

• Disease-free Survival Rate

  2 years

• Overall Survival Rate

  2 years

• Sites of Relapse

  2 years

Study Arms (1)

Oxaliplatin

EXPERIMENTAL

Oxaliplatin-70mg/m2 IV over 120 min once a week during radiation. Radiation-200 centigray (cGy) per day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday.

Drug: Oxaliplatin; Procedure: Radiation

Interventions

Oxaliplatin DRUG

70mg/m2 IV over 120 min once a week during radiation

Also known as: Eloxatin

Oxaliplatin

Radiation PROCEDURE

200 cGy/day - Megavoltage equipment with energy of Cobalt 60 or higher - Daily from Monday to Friday

Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. 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.
• All subjects must be 18 years of age or older.
• Subjects must have a Zubrod performance of 0-2.

You may not qualify if:

• Subjects must not have distant metastatic disease (M1).
• 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.
• Patients with severe psychiatric disorder are not eligible.
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years.

Sponsors & Collaborators

• University of California, Irvine: lead
• Sanofi: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Oxaliplatin; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Physical Phenomena

Results Point of Contact

• Title: Chao Family Comprehensive Cancer Center
• Organization: University of California, Irvine

UCstudy@uci.edu

(877) 827-8839

Study Officials

• Sai-Hong Ignatius Ou, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Associate Clinical Professor

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: February 1, 2005
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2011
• Last Updated: May 1, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)