Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02687 | Registry Identifier | Clinical Trial Reporting Program (CTRP) |
Not provided
Not provided
Not provided
Recruitment problems with study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together with radiation therapy and surgery works in treating patients with advanced cancer of the oral cavity, oropharynx, or hypopharynx that can be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14, and then periodically thereafter for biomarker correlative studies.
Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of treatment, and then annually thereafter.
After completion of study treatment, patients are followed every 2 months for 1 year and then periodically thereafter.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (neoadjuvant, adjuvant chemotherapy and radiation) | Experimental | PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Treatment | Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Interval and Failure Sites | Assess disease-free interval and failure sites of a new treatment regimen. | Up to one year |
| Correlation of Quality of Life With Treatment Outcome | Assess quality of life with treatment outcome will be obtained at baseline (prior to treatment) and at 6 months post treatment and one year post-treatment follow-ups. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Molecular Markers With Treatment Outcome | Evaluate potential correlative molecular markers with treatment outcome | Up to week 14 |
Inclusion Criteria:
Patients must have a Karnofsky Performance Index ≥60%
Patients must be over the age of 18.
Patients must have a life expectancy of at least 6 months.
Women of childbearing age must have a negative serum pregnancy test and agree to use an effective method of contraceptive.
Patients with a cardiac history should be cleared with a medical internist. In general, patients with a history of prior bradyarrythmias, atrioventricular (AV) conduction defects or marginal cardiac function will be eligible.
Patients must have resectable stage III, stage IVA, stage IVB (without distant metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Hypopharyngeal carcinomas may also be stage II.
Patients must not have had prior chemotherapy or radiotherapy (to the primary site or nodes).
Patients may not be planning to receive while on study concomitant immunotherapy or hormonal therapy, except oral contraceptives or hormone replacement therapy.
Patients must have adequate hepatic function documented by a normal serum bilirubin 0- 1.5mg/L and serum transaminases < 4 x upper limit.
Patients must have adequate renal function documented by a serum creatinine not above upper institutional normal limits and/or 24 hour OR calculated creatinine clearance >60 ml/min. using the following formula:
(140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine (mg/dl) female)
Patients must have adequate bone marrow function documented by platelet count ≥ 100,000 and absolute neutrophil count ≥ 2,000.
Patients will have surgery according to Section 5.3. Operative and pathology reports must be sufficiently detailed to confirm that surgery was done according to the guidelines.
Patients must be examined by a multi-modality team (consisting of a head and neck surgeon, medical oncologist, and radiation oncologist) prior to entry on study.
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enver Ozer, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
Not provided
| Label | URL |
|---|---|
| Jamesline | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 |
|
|
| Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation | Radiation | Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2. |
|
|
| Triple endoscopy and biopsy | Procedure | Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies. |
|
| Up to one year |
| Percentage of Participants With Serious Adverse Events | Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen. | Up to one year |
| Treatment Completion | Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year. | up to one year |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Feasibility of Treatment | Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy | The data was not collected or analyzed due to discontinuation of study in early stages. | Posted | Up to one year |
|
| |||||||||||||||||||
| Secondary | Disease-free Interval and Failure Sites | Assess disease-free interval and failure sites of a new treatment regimen. | The data was not collected or analyzed due to discontinuation of study in early stages. | Posted | Up to one year |
|
| |||||||||||||||||||
| Secondary | Correlation of Quality of Life With Treatment Outcome | Assess quality of life with treatment outcome will be obtained at baseline (prior to treatment) and at 6 months post treatment and one year post-treatment follow-ups. | The data analysis was unable to be completed due to discontinuation of study in early stages | Posted | Up to one year |
|
| |||||||||||||||||||
| Secondary | Percentage of Participants With Serious Adverse Events | Determine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen. | Posted | Number | percentage of patients | Up to one year |
|
| ||||||||||||||||||
| Secondary | Treatment Completion | Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year. | The data analysis was unable to be completed due to discontinuation of study in early stages | Posted | Number | patients | up to one year |
|
| |||||||||||||||||
| Other Pre-specified | Correlation of Molecular Markers With Treatment Outcome | Evaluate potential correlative molecular markers with treatment outcome | The data was not collected or analyzed due to discontinuation of study in early stages. | Posted | Up to week 14 |
|
|
Not provided
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation) | PREOPERATIVE:Patients receive cisplatin IV over 2 hours 3 times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation. POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10. Cisplatin: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. Paclitaxel: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nod | 2 | 11 | 11 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Chemoradiation | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extremity pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Edema-limb | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Oral cavity pain | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Salivary gland changes | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment | oral cavity |
|
| Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes/ANC | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Throat/pharynx, larynx pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment | sensory |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| ALT (serum glutamic pyruvic transaminase) | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Face pain | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Edema-head and neck | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE version 3.0 | Systematic Assessment | Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis) |
|
The study was stopped in the early stages and no data analysis was completed and results produced.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enzer Ozer, MD | The Ohio State University Comprehensive Cancer Center | 614-293-8074 | enver.ozer@osumc.edu |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| D011878 | Radiotherapy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D013812 | Therapeutics |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Participants |
|
|
|
|
|
|