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

NCT00448552 | Completed Phase 2 DMC

• 3 other identifiers: 20030243SCCC-2003050WIRB-20060071
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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; stage IV inverted papilloma of the paranasal sinus and nasal cavity; stage IV midline lethal granuloma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; stage IV salivary gland cancer; untreated metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (complete response and partial response)

Secondary Outcomes (2)

• Toxicity as measured by NCI CTC

• Survival

Interventions

capecitabine DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Esthesioneuroblastoma, Olfactory; Salivary Gland Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Luis E. Raez, MD, FACP

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: February 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2008
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)