Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

NCT00266279 | Completed Phase 2 Results DMC

• 1 other identifier: 153.05
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.

Conditions

Head or Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Overall Response Rate (ORR)=PR+CR.

  Every two 28 day treatment cycles until subject no longer on treatment due to disease progression

Secondary Outcomes (1)

• Qualitative and Quantitative Toxicity

  At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression

Study Arms (1)

Treatment with Study Drugs

EXPERIMENTAL

Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.

Drug: Oxaliplatin, Capecitabine

Interventions

Oxaliplatin, Capecitabine DRUG

Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

Treatment with Study Drugs

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed squamous cell cancer of Head and Neck
• Patients must have metastatic or locally recurrent disease
• Patients must have disease not curable by surgery as estimated by one of the protocol investigators, and should not be eligible for reradiation protocol or have failed reradiation protocol.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan
• Age \>18 years of age
• Life expectancy of greater than 12 weeks
• ECOG performance status 0, 1 or 2 (Karnofsky \>50%; see Appendix B)
• Patients must have adequate bone marrow function as defined below:
• absolute neutrophil count \> 1,500
• platelets \> 100,000
• hemoglobin \> 8 g/dl
• Patients must have adequate renal function as defined by a creatinine clearance \>30 mL/min (measured or estimated by the Cockroft and Gault equation)
• Cockroft and Gault equation:
• Creatinine clearance for males =(140-age\[yrs\])(body wt\[kg\])/72(serum creatinine\[mg/dL\])
• Creatinine clearance for females = 0.85 x male value

You may not qualify if:

• Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or oxaliplatin
• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first treatment in this study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients receiving any other investigational agent(s)
• Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events)
• Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ
• Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart Association Class II or greater, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
• If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure. See attached Appendix G.
• Patients who have had an organ allograft.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy
• Known Hepatitis B , Hepatitis C, HIV
• Members of all ethnic groups are eligible for this trial.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

University of Louisville, James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Rabinowits G, Bhupalam L, Miller DM, Kloecker GH, Laber DA. Fixed-dose every-other-week capecitabine and oxaliplatin for refractory squamous cell carcinoma of the head and neck. Am J Med Sci. 2010 Feb;339(2):148-51. doi: 10.1097/MAJ.0b013e3181c4bd91.

  PMID: 20087165 RESULT

Related Links

• James Graham Brown Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Results data not available, PI not longer at institution

Results Point of Contact

• Title: University of Louisville, James Graham Brown Cancer Center Clinical Trials
• Organization: University of Louisville, James Graham Brown Cancer Center

bcccto@louisville.edu

502-562-3429

Study Officials

• Damian Laber, M.D.

  University of Louisville, James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 16, 2005
• Study Start: April 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 3, 2020
• Results First Posted: October 31, 2014

Record last verified: 2020-08

Locations

US (1)