Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00591149
• Collaborator: Sanofi (Industry)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 58
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Carcinoma, Squamous	Drug: Oxaliplatin; Drug: Docetaxel; Drug: Cetuximab	Phase 2

Detailed Description

This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1 Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.

Drug: Oxaliplatin; 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles; Other Names: Eloxatin ; Drug: Docetaxel; 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles; Other Names: Taxotere ; Drug: Cetuximab; 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks; Other Names: Erbitux

Outcome Measures

Primary Outcome Measures

1. Efficacy Measured by Response Rate in Participants [12 Weeks, 1 Year]

   Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically or cytologically confirmed recurrent SCCHN

• 18 years or older

• Tumor site accessible by biopsy

• Measurable disease

• Receiving no other therapy

• ECOG performance status 0-1

• Adequate bone marrow, renal function and hepatic function

Exclusion Criteria:

• Active infection or fever within 3 days of treatment

• Active CNS metastases

• Prior malignancy within 5 years

• Hypersensitivity to study drugs

• Chemotherapy within 30 days of treatment

• Concurrent investigational therapy within 30 days

• Radiotherapy of more than 25% of bone marrow

• Peripheral neuropathy of grade 2 or greater

• Pregnant or lactating patients

• History of allogeneic transplant

• Active or previously treated HIV or Hepatitis B or C

• Patients with a tracheostomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center
• Sanofi

Investigators

• Principal Investigator: Chao Huang, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00591149
• Other Study ID Numbers: 10635
• First Posted: Jan 11, 2008
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

• Keywords provided by University of Kansas Medical Center: cancer; head and neck cancer; squamous cell cancer
• Additional relevant MeSH terms: Carcinoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Docetaxel; Oxaliplatin; Cetuximab

Study Results

Participant Flow

Arm/Group Title	Oxaliplatin and Docetaxel
Arm/Group Description	Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity. Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
Period Title: Overall Study
STARTED	16
COMPLETED	11
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Oxalipatin and Docetaxel
Arm/Group Description	Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity. Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Overall Participants	16
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	16 100%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy Measured by Response Rate in Participants
Description	Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	12 Weeks, 1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxaliplatin and Docetaxel
Arm/Group Description	Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity. Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks
Measure Participants	16
Complete Response	0 0%
Partial Response	2 12.5%
Stable Disease	6 37.5%
Progressive Disease	3 18.8%
Not Evaluable	5 31.3%

Adverse Events

Arm/Group Title	Oxaliplatin and Docetaxel
Arm/Group Description	Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity. Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles
All Cause Mortality
	Oxaliplatin and Docetaxel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Oxaliplatin and Docetaxel
	Affected / at Risk (%)	# Events
Total	10/16 (62.5%)
Blood and lymphatic system disorders
Febrile Neutropenia	2/16 (12.5%)	2
Gastrointestinal disorders
Abdominal Pain	1/16 (6.3%)	1
Constipation	1/16 (6.3%)	1
Diarrhea	1/16 (6.3%)	1
Nausea	1/16 (6.3%)	1
Vomiting	1/16 (6.3%)	1
General disorders
Fever	1/16 (6.3%)	1
Multi-organ failure	1/16 (6.3%)	1
Immune system disorders
Allergic reaction	1/16 (6.3%)	1
Infections and infestations
Infection, lung (Pneumonia)	2/16 (12.5%)	3
Sepsis	2/16 (12.5%)	2
Respiratory, thoracic and mediastinal disorders
Aspiration	1/16 (6.3%)	1
Bronchopulmonary hemorrhage	1/16 (6.3%)	1
Other (Not Including Serious) Adverse Events
	Oxaliplatin and Docetaxel
	Affected / at Risk (%)	# Events
Total	16/16 (100%)
Blood and lymphatic system disorders
Anemia	1/16 (6.3%)	4
Hemoglobin	2/16 (12.5%)	4
Hemolysis	5/16 (31.3%)	12
Leukopenia	9/16 (56.3%)	21
Neutropenia	6/16 (37.5%)	12
Decreased platelets	5/16 (31.3%)	7
Ear and labyrinth disorders
Abnormal ear, nose and throat examination	1/16 (6.3%)	1
Hearing	1/16 (6.3%)	1
Gastrointestinal disorders
Constipation	1/16 (6.3%)	1
Diarrhea	4/16 (25%)	6
Dysphagia	1/16 (6.3%)	1
Mucositis oral	1/16 (6.3%)	1
Nausea	5/16 (31.3%)	7
Vomiting	3/16 (18.8%)	4
General disorders
Edema: limbs	2/16 (12.5%)	2
Edema: Head and Neck	1/16 (6.3%)	1
Fatigue	10/16 (62.5%)	20
Infections and infestations
Colitis	1/16 (6.3%)	1
Esophagitis	1/16 (6.3%)	1
Fever	3/16 (18.8%)	5
Gastritis	1/16 (6.3%)	1
Infection, mucosa	1/16 (6.3%)	1
Lung infection: Pneumonia	2/16 (12.5%)	2
Skin infection	1/16 (6.3%)	2
Injury, poisoning and procedural complications
Bruising	1/16 (6.3%)	3
Radiation recall reaction (dermatologic)	1/16 (6.3%)	1
Vascular access complication	1/16 (6.3%)	1
Investigations
Alanine aminotrasferase increased	4/16 (25%)	5
Aspartate aminotrasferase increased	4/16 (25%)	8
Creatinine increased	3/16 (18.8%)	4
Elevated Alkaline Phosphatase	1/16 (6.3%)	1
Elevated blood urea nitrogen	2/16 (12.5%)	3
Hyperbilirubinemia	1/16 (6.3%)	1
Metabolism and nutrition disorders
Anorexia	5/16 (31.3%)	8
Dehydration	1/16 (6.3%)	1
Hyperglycemia	3/16 (18.8%)	4
Hypokalemia	5/16 (31.3%)	17
Hypermagnesemia	1/16 (6.3%)	1
Hyperkalemia	2/16 (12.5%)	2
Hypernatremia	1/16 (6.3%)	1
Hypomagnesemia	2/16 (12.5%)	2
Hyponatremia	5/16 (31.3%)	11
Musculoskeletal and connective tissue disorders
Bone pain	2/16 (12.5%)	4
Joint pain	1/16 (6.3%)	1
Muscle weakness: lower limb	1/16 (6.3%)	1
Myalgia	2/16 (12.5%)	2
Trismus	1/16 (6.3%)	1
Weakness	1/16 (6.3%)	1
Nervous system disorders
Headache	2/16 (12.5%)	2
Peripheral sensory neuropathy	6/16 (37.5%)	13
Syncope	1/16 (6.3%)	1
dysgeusia	1/16 (6.3%)	1
Trigeminal nerve disorder	1/16 (6.3%)	1
Psychiatric disorders
Depression	1/16 (6.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	2/16 (12.5%)	3
Dyspnea	4/16 (25%)	5
Hiccup	1/16 (6.3%)	1
Rhinitis	1/16 (6.3%)	1
Voice alteration	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Alopecia	4/16 (25%)	6
Hyperpigmentation	1/16 (6.3%)	1
Nail changes	1/16 (6.3%)	1
Tissue necrosis: neck	1/16 (6.3%)	1
Rash	4/16 (25%)	6

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.