search
Back to results

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

Primary Purpose

Carcinoma of the Head and Neck

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Taxotere
Oxaliplatin
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of the Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.

Outcomes

Primary Outcome Measures

Tumor Response
All eligible patients who received the first dose of Taxotere will be included in the analysis. Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease. Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Secondary Outcome Measures

Number of Participants With Serious Adverse Events (SAEs)
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Full Information

First Posted
September 12, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00184028
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
Intervention Type
Drug
Intervention Name(s)
Taxotere
Intervention Description
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.
Primary Outcome Measure Information:
Title
Tumor Response
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 (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease. Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame
6 months after the last subject enrolled has gone off study
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame
At end of every cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Gitlitz, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs