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

• Sponsor: University of Southern California (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00184028
• Collaborator: Sanofi (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 69.9
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of the Head and Neck	Drug: Taxotere; Drug: Oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tumor Response [6 months after the last subject enrolled has gone off study]

   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

1. Number of Participants With Serious Adverse Events (SAEs) [At end of every cycle]

   Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California
• Sanofi

Investigators

• Principal Investigator: Barbara Gitlitz, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Southern California
• ClinicalTrials.gov Identifier: NCT00184028
• Other Study ID Numbers: 7H-03-1
• First Posted: Sep 16, 2005
• Last Update Posted: May 22, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Oxaliplatin; Docetaxel

Study Results

Participant Flow

Recruitment Details	Participants were recruited at USC/Los Angeles County General Hospital and the USC/Norris Cancer Hopital between March 2005 and October 2007.
Pre-assignment Detail	The trial had no pre-assignment criteria. All subjects were given the same treatment.

Arm/Group Title	Taxotere Followed by Oxaliplatin
Arm/Group 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.
Period Title: Overall Study
STARTED	12
COMPLETED	2
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Taxotere Followed by Oxaliplatin
Arm/Group 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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 83.3%
>=65 years	2 16.7%
Sex: Female, Male (Count of Participants)
Female	3 25%
Male	9 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%
Not Hispanic or Latino	10 83.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 16.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 16.7%
White	6 50%
More than one race	0 0%
Unknown or Not Reported	2 16.7%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Single arm study
Measure Participants	12
Complete Response	0 0%
Partial Response	1 8.3%
Stable Disease	5 41.7%
Progressive Disease	2 16.7%
Early Offstudy (refused further therapy)	3 25%
Early Death (due to malignant disease)	1 8.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who started treatment

Arm/Group Title	Taxotere Followed by Oxaliplatin
Arm/Group 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.
Measure Participants	12
Number [Participants]	7 58.3%

Adverse Events

Time Frame	Adverse events were collected from the time the subject received the initial Taxotere and Oxaliplatin infusion and continued throughout the study until 30 days afer the last dose.
Arm/Group Title	Taxotere Followed by Oxaliplatin
Arm/Group 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.
All Cause Mortality
	Taxotere Followed by Oxaliplatin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Taxotere Followed by Oxaliplatin
	Affected / at Risk (%)	# Events
Total	7/12 (58.3%)
Blood and lymphatic system disorders
Hemoglobin	1/12 (8.3%)	2
Gastrointestinal disorders
Nausea	1/12 (8.3%)	1
General disorders
Death not associated with CTCAE term (Death NOS)	1/12 (8.3%)	1
Fatigue	1/12 (8.3%)	1
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)	1/12 (8.3%)	1
Infections and infestations
Infection (documented clinically or microbiologically)	1/12 (8.3%)	1
Investigations
Leukocytes (total WBC)	2/12 (16.7%)	2
Neutrophils/Granulocytes (ANC/AGC)	1/12 (8.3%)	1
Metabolism and nutrition disorders
Anorexia	3/12 (25%)	3
Calcium, serum-high (hypercalcemia)	1/12 (8.3%)	1
Phosphate, serum-low (Hypophosphatemia)	1/12 (8.3%)	1
Potassium, serum-low (Hypokalemia)	1/12 (8.3%)	1
Nervous system disorders
Neuropathy: cranial (CN VII motor-face; sensory-taste)	1/12 (8.3%)	1
Psychiatric disorders
Insomnia	1/12 (8.3%)	1
Mood Alteration (Agitation)	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	2/12 (16.7%)	2
Other (Not Including Serious) Adverse Events
	Taxotere Followed by Oxaliplatin
	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)
Blood and lymphatic system disorders
Hemoglobin	9/12 (75%)	14
Cardiac disorders
Pain (cardiac/heart)	1/12 (8.3%)	2
Supraventricular and nodal arrythmia (Sinus tachycardia)	2/12 (16.7%)	2
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in monitoring program	1/12 (8.3%)	1
Pain (middle ear)	1/12 (8.3%)	1
Gastrointestinal disorders
Constipation	4/12 (33.3%)	4
Pain (Abdomen NOS)	1/12 (8.3%)	1
Heartburn/Dyspepsia	1/12 (8.3%)	1
Vomiting	3/12 (25%)	3
Nausea	2/12 (16.7%)	2
General disorders
Fever (in the absence of neutropenia)	2/12 (16.7%)	2
Fatigue (asthenia, lethargy, malaise)	3/12 (25%)	3
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Soft Tissue NOS)	1/12 (8.3%)	1
Investigations
Platelets	1/12 (8.3%)	1
Leukocytes (total WBC)	3/12 (25%)	3
Alkaline Phosphatase	1/12 (8.3%)	1
INR (International Normalized Ratio of Prothrombin)	2/12 (16.7%)	2
PTT (Partial Thromboplastin Time)	1/12 (8.3%)	1
ALT, SGPT (serum glutamic pyruvic transaminase)	2/12 (16.7%)	3
Weight Loss	1/12 (8.3%)	1
AST, SGOT (serum glutamic oxaloacetic transaminase)	3/12 (25%)	3
Neutrophils/granulocytes (ANC/AGC)	1/12 (8.3%)	1
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)	8/12 (66.7%)	10
Dehydration	4/12 (33.3%)	4
Magnesium, serum-low (hypomagnesemia)	2/12 (16.7%)	3
Potassium, serum-low (hypokalemia)	2/12 (16.7%)	4
Calcium, serum-low (hypcalcemia)	1/12 (8.3%)	1
Bicarbonate, serum-low	1/12 (8.3%)	1
Sodium, serum-low (hyponatremia)	1/12 (8.3%)	1
Phosphate, serum-low (hypophosphatemia)	2/12 (16.7%)	3
Albumin, serum-low (hypoalbuminemia)	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Pain (muscle)	2/12 (16.7%)	2
Pain (neck)	1/12 (8.3%)	1
Nervous system disorders
Taste alteration (dysgeusia)	4/12 (33.3%)	4
Pain (Head/headache)	3/12 (25%)	3
Neuropathy: Sensory	2/12 (16.7%)	2
Neuropathy: motor	1/12 (8.3%)	1
Ataxia (incoordination)	1/12 (8.3%)	1
Dizziness	2/12 (16.7%)	2
Psychiatric disorders
Insomnia	6/12 (50%)	6
Mood Alteration (Anxiety)	3/12 (25%)	3
Mood alteration (Agitation)	1/12 (8.3%)	1
Mood alteration (Depression)	2/12 (16.7%)	2
Respiratory, thoracic and mediastinal disorders
Cough	2/12 (16.7%)	2
Pneumonitis/pulmonary infiltrates	1/12 (8.3%)	1
Dyspnea (shortness of breath)	4/12 (33.3%)	4
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)	5/12 (41.7%)	6
Rash/desquamation	1/12 (8.3%)	1
Nail changes	2/12 (16.7%)	3
Hyperpigmentation	1/12 (8.3%)	1
Vascular disorders
Flushing	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.