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

Carcinoma of the Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00184028
• Other study ID #: 7H-03-1
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 20, 2014
• Start date: September 2004
• Est. completion date: July 2010

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Taxotere
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
• Oxaliplatin
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min. on day 1 every 3 weeks.

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after the last subject enrolled has gone off study	No
Secondary	Number of Participants With Serious Adverse Events (SAEs)	Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.	At end of every cycle	Yes