Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck

Stopped early · Phase 2

Conditions studied: Carcinoma of the Head and Neck

In brief

This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer. Approximately 54 subjects will take part in this study.

Key facts

Study ID: NCT00184028
Run by: University of Southern California
People needed: 12
Starts: 2004-09-01
Expected to finish: 2010-07-01
Last updated by the study team: 2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection. If it is not available, a repeat biopsy must be performed.
Age greater than or equal to 18 years
ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
Patients must have adequate organ and marrow function as defined below:
leukocytes greater than or equal to 3,000/microliter
hemoglobin greater than or equal to 8.0 g/dl
absolute neutrophil count greater than or equal to 1,500/microliter
platelets greater than or equal to 100,000/microliter
total bilirubin within normal institutional limits
creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
If:
ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to ULN, patient is eligible.
ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is eligible.
ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN, patient is ineligible.
ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less than or equal to ULN, patient is eligible.
ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible.
ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 5x ULN, patient is ineligible.
ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less than or equal to ULN,patient is eligible.
ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1x but less than or equal to 1.5x, patient is ineligible.
ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1.5x but less than or equal to 5x, patient is ineligible.
ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 5x ULN, patient is ineligible.
ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN, patient is ineligible.

You may not qualify if…

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
Patients undergoing therapy with other investigational agents.
Previous treatment involving regimen utilizing any of the protocol chemotherapeutic agents
Patients with known brain metastases
History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs formulated with polysorbate 80
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
Pregnant and nursing women
HIV-positive patients

Where it is running

USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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