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Sponsored by: |
Sylvester Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00448552 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: capecitabine Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine |
Estimated Enrollment: | 30 |
Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed head and neck cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 6 months since prior adjuvant fluoropyrimidine therapy
At least 6 months since prior adjuvant platinum-based therapy
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 |
Study Chair: | Luis E. Raez, MD, FACP | Sylvester Cancer Center |
Study ID Numbers: | CDR0000535970, SCCC-2003050, SCCC-20030243, SCCC-03/243C, SCCC-20060071, SANOFI-SCCC-2003050 |
Study First Received: | March 15, 2007 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00448552 |
Health Authority: | United States: Federal Government |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity |
stage IV verrucous carcinoma of the oral cavity recurrent metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent midline lethal granuloma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity |
Capecitabine Squamous cell carcinoma Carcinoma, Basal Cell Granuloma Adenoid cystic carcinoma Dental Caries Recurrence Carcinoma Epidermoid carcinoma Oxaliplatin |
Nasopharyngeal carcinoma Carcinoma, Adenoid Cystic Metastatic squamous neck cancer with occult primary Head and Neck Neoplasms Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Carcinoma, Squamous Cell Papilloma Salivary Gland Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |