Clinical trial NCT00184028: Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
Official title: Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma of the Head and Neck
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.
  * ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is ineligible
  * ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible
  * ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is ineligible
* Patients with neuropathy \< 1.
* Ability to understand and the willingness to sign a written informed consent document
* Women of childbearing potential must have a negative pregnancy test
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tumor Response
timeFrame: 6 months after the last subject enrolled has gone off study
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: At end of every cycle
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Barbara Gitlitz, MD
role: PRINCIPAL_INVESTIGATOR
References: