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Study was stopped due to termination of funding
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Measured by Response Rate in Participants | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:
| 12 Weeks, 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chao Huang, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxaliplatin and Docetaxel | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxalipatin and Docetaxel | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy Measured by Response Rate in Participants | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI:
| Posted | Number | participants | 12 Weeks, 1 Year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxaliplatin and Docetaxel | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotrasferase increased | Investigations | CTCAE (3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chao Huang, MD | University of Kansas Medical Center | 913-588-6029 | chuang2@kumc.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000077143 | Docetaxel |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Docetaxel | Drug | 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles |
|
|
| Cetuximab | Drug | 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 10 |
| 16 |
| 16 |
| 16 |
| Allergic reaction | Immune system disorders | CTCAE (3.0) |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Fever | General disorders | CTCAE (3.0) |
|
| Infection, lung (Pneumonia) | Infections and infestations | CTCAE (3.0) |
|
| Multi-organ failure | General disorders | CTCAE (3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Sepsis | Infections and infestations | CTCAE (3.0) |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Aspartate aminotrasferase increased | Investigations | CTCAE (3.0) |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Colitis | Infections and infestations | CTCAE (3.0) |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Creatinine increased | Investigations | CTCAE (3.0) |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Depression | Psychiatric disorders | CTCAE (3.0) |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Abnormal ear, nose and throat examination | Ear and labyrinth disorders | CTCAE (3.0) |
|
| Edema: limbs | General disorders | CTCAE (3.0) |
|
| Edema: Head and Neck | General disorders | CTCAE (3.0) |
|
| Elevated Alkaline Phosphatase | Investigations | CTCAE (3.0) |
|
| Elevated blood urea nitrogen | Investigations | CTCAE (3.0) |
|
| Esophagitis | Infections and infestations | CTCAE (3.0) |
|
| Fatigue | General disorders | CTCAE (3.0) |
|
| Fever | Infections and infestations | CTCAE (3.0) |
|
| Gastritis | Infections and infestations | CTCAE (3.0) |
|
| Headache | Nervous system disorders | CTCAE (3.0) |
|
| Hearing | Ear and labyrinth disorders | CTCAE (3.0) |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Hiccup | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Infection, mucosa | Infections and infestations | CTCAE (3.0) |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) |
|
| Muscle weakness: lower limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Tissue necrosis: neck | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) |
|
| Decreased platelets | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Lung infection: Pneumonia | Infections and infestations | CTCAE (3.0) |
|
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Skin infection | Infections and infestations | CTCAE (3.0) |
|
| Syncope | Nervous system disorders | CTCAE (3.0) |
|
| dysgeusia | Nervous system disorders | CTCAE (3.0) |
|
| Trigeminal nerve disorder | Nervous system disorders | CTCAE (3.0) |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
|
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
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| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |