Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448552
• Other study ID #: 20030243
• Secondary ID: SCCC-2003050WIRB
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: December 14, 2016
• Start date: February 2004
• Est. completion date: June 2008

Study information

• Verified date: December 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with capecitabine works in treating patients with relapsed or metastatic head and neck cancer.

Description:

OBJECTIVES:

Primary

• Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine.

Secondary

• Evaluate the safety and toxicity of this regimen in these patients.

• Determine the one-year survival and overall survival of these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed head and neck cancer

• Relapsed or metastatic disease

• Measurable disease

• No CNS metastases (unless CNS metastases have been stable for > 3 months)

• No clinically significant pericardial effusion

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 3 months

• Absolute granulocyte count > 1,500/mm³

• Platelet count > 100,000/mm³

• Bilirubin < 2.0 times upper limit of normal (ULN)

• AST or ALT < 2.5 times ULN

• Alkaline phosphatase < 2.5 times ULN (5 times ULN if liver metastases are present or 10 times ULN if bone disease is present)

• Creatinine clearance = 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after completion of study treatment

• No clinically serious, uncontrolled cardiovascular disease

• No New York Heart Association class III-IV heart disease

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No unstable angina

• No arrhythmia

• No concurrent serious, uncontrolled infections

• No other cancer requiring treatment within the past 5 years, except cured nonmelanoma skin cancer or treated in situ cervical cancer

• No loss of physical integrity of the upper gastrointestinal tract or malabsorption syndrome

• No history of persistent neurosensory disorder including, but not limited to, peripheral neuropathy

• No history of uncontrolled seizures or CNS disorders

• No history of psychiatric disability or other serious uncontrolled medical condition that would preclude study compliance

• No history of clinically significant interstitial lung disease and/or pulmonary fibrosis

• No prior hypersensitivity or unanticipated severe reaction to fluoropyrimidine therapy, fluorouracil, or platinum-based compounds

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic or relapsed disease

• More than 4 weeks since prior major surgery and recovered

• More than 4 weeks since prior participation in any investigational drug study

• At least 6 months since prior adjuvant fluoropyrimidine therapy

• No other prior fluoropyrimidines

• At least 6 months since prior adjuvant platinum-based therapy

• No other prior platinum-based therapy

• No concurrent radiotherapy to the head and neck

• No other concurrent chemotherapy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• capecitabine

• oxaliplatin

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (complete response and partial response)			No
Secondary	Toxicity as measured by NCI CTC			Yes
Secondary	Survival			No