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Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma of the Head and Neck

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Trial Information

Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Description:

All eligible patients who received the first dose of Taxotere will be included in the analysis. Tumor Response will be categorized as: Complete Response, Partial Response, Stable Disease, Progressive Disease, Early Death from Malignant Disease, Early Death from Toxicity, Early Death Because of Other Cause, Unknown (not assessable, insufficient data), or Never Received Any of the Drugs, Taxotere or Oxaliplatin.

Outcome Time Frame:

6 months after the last subject enrolled has gone off study

Safety Issue:

No

Principal Investigator

Barbara Gitlitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

7H-03-1

NCT ID:

NCT00184028

Start Date:

September 2004

Completion Date:

July 2010

Related Keywords:

  • Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800