Trial Outcomes & Findings for Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer (NCT NCT00566540)
NCT ID: NCT00566540
Last Updated: 2021-11-26
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to one year
Results posted on
2021-11-26
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
n=11 Participants
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
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|---|---|
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Age, Continuous
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63 years
n=5 Participants
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|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to one yearPopulation: The data was not collected or analyzed due to discontinuation of study in early stages.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: The data was not collected or analyzed due to discontinuation of study in early stages.
Assess disease-free interval and failure sites of a new treatment regimen.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearPopulation: The data analysis was unable to be completed due to discontinuation of study in early stages
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to one yearDetermine the frequency and severity of toxicities of the intensification regimen. Patients will be evaluated for local and systemic toxicity/morbidity from treatment regimen.
Outcome measures
| Measure |
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
n=11 Participants
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
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|---|---|
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Percentage of Participants With Serious Adverse Events
Rash
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9 percentage of patients
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Percentage of Participants With Serious Adverse Events
Colitis
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9 percentage of patients
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Percentage of Participants With Serious Adverse Events
Dehydration
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18 percentage of patients
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Percentage of Participants With Serious Adverse Events
Diarrhea
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9 percentage of patients
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|
Percentage of Participants With Serious Adverse Events
Vomiting
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9 percentage of patients
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|
Percentage of Participants With Serious Adverse Events
Hemorrhage, Upper Respiratory
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9 percentage of patients
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Percentage of Participants With Serious Adverse Events
Infection with normal ANC
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9 percentage of patients
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Percentage of Participants With Serious Adverse Events
Edema
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9 percentage of patients
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Percentage of Participants With Serious Adverse Events
Leukocytes
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9 percentage of patients
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SECONDARY outcome
Timeframe: up to one yearPopulation: The data analysis was unable to be completed due to discontinuation of study in early stages
Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year.
Outcome measures
| Measure |
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
n=11 Participants
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
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|---|---|
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Treatment Completion
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7 patients
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 14Population: The data was not collected or analyzed due to discontinuation of study in early stages.
Evaluate potential correlative molecular markers with treatment outcome
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
Serious events: 11 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
n=11 participants at risk
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
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|---|---|
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Blood and lymphatic system disorders
Leukocytes (total WBC)
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
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Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation - Chemoradiation
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Dehydration
|
18.2%
2/11 • Number of events 2
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
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Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS
|
9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
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Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
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9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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Blood and lymphatic system disorders
Edema: limb
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9.1%
1/11 • Number of events 1
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
Other adverse events
| Measure |
Treatment (Neoadjuvant, Adjuvant Chemotherapy and Radiation)
n=11 participants at risk
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
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|---|---|
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Musculoskeletal and connective tissue disorders
Extremity pain
|
54.5%
6/11 • Number of events 6
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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General disorders
Edema-limb
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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Gastrointestinal disorders
Oral cavity pain
|
90.9%
10/11 • Number of events 10
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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Metabolism and nutrition disorders
Hyperglycemia
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36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
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Gastrointestinal disorders
Salivary gland changes
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36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
90.9%
10/11 • Number of events 10
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
54.5%
6/11 • Number of events 6
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
3/11 • Number of events 3
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
General disorders
Fatigue
|
90.9%
10/11 • Number of events 10
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
90.9%
10/11 • Number of events 10
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes/ANC
|
45.5%
5/11 • Number of events 5
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.3%
3/11 • Number of events 3
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
72.7%
8/11 • Number of events 8
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx, larynx pain
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Constipation
|
45.5%
5/11 • Number of events 5
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
45.5%
5/11 • Number of events 5
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Investigations
Weight loss
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
72.7%
8/11 • Number of events 8
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Nervous system disorders
Neuropathy
|
63.6%
7/11 • Number of events 7
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Vomiting
|
81.8%
9/11 • Number of events 9
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
72.7%
8/11 • Number of events 8
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Investigations
ALT (serum glutamic pyruvic transaminase)
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
81.8%
9/11 • Number of events 9
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
81.8%
9/11 • Number of events 9
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
General disorders
Face pain
|
36.4%
4/11 • Number of events 4
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
General disorders
Edema-head and neck
|
81.8%
9/11 • Number of events 9
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
|
Infections and infestations
Infection
|
63.6%
7/11 • Number of events 7
Adverse events were graded using the NCI Common Toxicity Criteria version 3.0.
|
Additional Information
Enzer Ozer, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8074
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place