Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Primary objective:
To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients with locally advanced non-metastatic HNSCC. The assessment of primary tumor site response will be performed by the treating physician by careful clinical examination using WHO criteria. Radiographic studies will also be performed to assess primary tumor site response but will be used primarily to confirm lack of disease progression that may not be detected based on clinical examination alone.
The secondary objectives include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Induction chemotherapy followed by Radiation therapy plus Cisplatin Induction chemotherapy: Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3. Post-Induction: Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42. |
|
| 2 | Experimental | Induction chemotherapy followed by Radiation therapy plus Cetuximab Induction chemotherapy: Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3. Post-Induction: Radiation - Monday-Friday weeks 1-7 with concurrent Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | 100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response Rate at the Primary Tumor | Clinical exam included laryngoscopy in office or operating room. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. | post-2 cycles of induction (approximately 42 days from start of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Partial Response Rate at the Primary Tumor | Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Clinical Complete and Partial Response Rates to the Involved Regional Nodes |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complete and Partial Response Rates by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
Inclusion
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Adkins, M.D. | Washington Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2034244 | Background | Department of Veterans Affairs Laryngeal Cancer Study Group; Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. doi: 10.1056/NEJM199106133242402. | |
| Background | JCO 12:1592, 1194 | ||
| 16275937 |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was open from 12/19/08-10/18/11 at the Siteman Cancer Center (a medical clinic).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Induction Chemo + RT + Cisplatin or Cetuximab | Induction chemotherapy: Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3. Post-Induction: Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetuximab |
| Drug |
400 mg/m2 IVPB, Day 1, cycle 1 |
|
| Cetuximab | Drug | 250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3 |
|
| Cisplatin | Drug | 75 mg/m2 IVPB Day 1, cycles 1, 2 and 3 |
|
| 5-FU | Drug | 750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3 |
|
| Radiation (Post induction) | Radiation | Monday-Friday, weeks 1-7 |
|
| Cisplatin | Drug | (Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42 |
|
| Cetuximab | Drug | (Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB |
|
Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. |
| post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Clinical Overall Complete and Partial Response Rates | Clinical exam included laryngoscopy in office or operating room. Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. | post-2 cycles of induction therapy (approximately 42 days) |
| Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | SPARC expression = intensity of SPARC staining in tumor | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | SPARC expression = intensity of SPARC staining in tumor | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | completion of the first 10 patients induction chemotherapy |
| Overall Survival | Time from diagnosis to death or to last follow-up alive. | 10 years from completion of treatment |
| Disease Free Survival | Time from complete response to death from any cause, to disease progression or to last follow-up alive. | 10 years from completion of treatment |
| Time to Progression | Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive. | 10 years from completion of treatment |
| post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| Background |
| Hitt R, Lopez-Pousa A, Martinez-Trufero J, Escrig V, Carles J, Rizo A, Isla D, Vega ME, Marti JL, Lobo F, Pastor P, Valenti V, Belon J, Sanchez MA, Chaib C, Pallares C, Anton A, Cervantes A, Paz-Ares L, Cortes-Funes H. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005 Dec 1;23(34):8636-45. doi: 10.1200/JCO.2004.00.1990. Epub 2005 Nov 7. |
| 16314626 | Background | Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646. |
| Background | Kuperman, et al ASCO 2007 |
| Background | Kies, et al ASCO 2006 |
| 12844327 | Background | ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles : implications for cancer chemotherapy. Clin Pharmacokinet. 2003;42(7):665-85. doi: 10.2165/00003088-200342070-00005. |
| 10197613 | Background | Sparreboom A, van Zuylen L, Brouwer E, Loos WJ, de Bruijn P, Gelderblom H, Pillay M, Nooter K, Stoter G, Verweij J. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res. 1999 Apr 1;59(7):1454-7. |
| 15169793 | Background | Winer EP, Berry DA, Woolf S, Duggan D, Kornblith A, Harris LN, Michaelson RA, Kirshner JA, Fleming GF, Perry MC, Graham ML, Sharp SA, Keresztes R, Henderson IC, Hudis C, Muss H, Norton L. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol. 2004 Jun 1;22(11):2061-8. doi: 10.1200/JCO.2004.08.048. |
| 10496361 | Background | van Tellingen O, Huizing MT, Panday VR, Schellens JH, Nooijen WJ, Beijnen JH. Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients. Br J Cancer. 1999 Sep;81(2):330-5. doi: 10.1038/sj.bjc.6690696. |
| Background | Desai N, et al SABCS Dec, 2003 |
| 16172456 | Background | Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. doi: 10.1200/JCO.2005.04.937. Epub 2005 Sep 19. |
| Background | Gradishar,et al SABCS 2006 |
| Background | SABCS 2006 |
| 16012759 | Background | Kato Y, Nagashima Y, Baba Y, Kawano T, Furukawa M, Kubota A, Yanoma S, Imagawa-Ishiguro Y, Satake K, Taguchi T, Hata R, Mochimatsu I, Aoki I, Kameda Y, Inayama Y, Tsukuda M. Expression of SPARC in tongue carcinoma of stage II is associated with poor prognosis: an immunohistochemical study of 86 cases. Int J Mol Med. 2005 Aug;16(2):263-8. |
| 12237917 | Background | Mendez E, Cheng C, Farwell DG, Ricks S, Agoff SN, Futran ND, Weymuller EA Jr, Maronian NC, Zhao LP, Chen C. Transcriptional expression profiles of oral squamous cell carcinomas. Cancer. 2002 Oct 1;95(7):1482-94. doi: 10.1002/cncr.10875. |
| Background | Desai N, et al SABCS Dec, 2004 |
| 28797458 | Derived | Adkins D, Ley J, Oppelt P, Wildes TM, Gay HA, Daly M, Rich J, Paniello RC, Jackson R, Pipkorn P, Nussenbaum B, Trinkaus K, Thorstad W. nab-Paclitaxel-based induction chemotherapy with or without cetuximab for locally advanced head and neck squamous cell carcinoma. Oral Oncol. 2017 Sep;72:26-31. doi: 10.1016/j.oraloncology.2017.07.001. Epub 2017 Jul 8. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Definitive Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction Chemo + RT + Cisplatin or Cetuximab | Induction chemotherapy: Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3. Post-Induction: Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Clinical Complete Response Rate at the Primary Tumor | Clinical exam included laryngoscopy in office or operating room. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. | All patients who completed 2 cycles of induction therapy. | Posted | Number | participants | post-2 cycles of induction (approximately 42 days from start of treatment) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Partial Response Rate at the Primary Tumor | Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size. | Participants who completed 2 cycles of induction therapy | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Complete and Partial Response Rates to the Involved Regional Nodes | Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. | Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Overall Complete and Partial Response Rates | Clinical exam included laryngoscopy in office or operating room. Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days) |
|
| ||||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. | Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. | Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. | One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles. | 2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease. | Posted | Number | percentage of participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| ||||||||||||||||||||||||||||
| Secondary | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. | 12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease. | Posted | Number | percentage of participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| ||||||||||||||||||||||||||||
| Secondary | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. | 1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage. | Posted | Number | percentage of participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
| ||||||||||||||||||||||||||||
| Secondary | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields | Patients who had available tumor tissue for SPARC testing and were complete responders. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields | Patients who had available tumor tissue for SPARC testing and were partial responders. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | SPARC expression = intensity of SPARC staining in tumor | Patients who had available tumor tissue for SPARC testing and were complete responders. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | SPARC expression = intensity of SPARC staining in tumor | Patients who had available tumor tissue for SPARC testing and were partial responders. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
| |||||||||||||||||||||||||||
| Secondary | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Posted | Number | participants | completion of the first 10 patients induction chemotherapy |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from diagnosis to death or to last follow-up alive. | Posted | Mean | Standard Error | months | 10 years from completion of treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival | Time from complete response to death from any cause, to disease progression or to last follow-up alive. | Posted | Mean | Standard Error | months | 10 years from completion of treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Progression | Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive. | Posted | Mean | Standard Error | months | 10 years from completion of treatment |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Overall Complete and Partial Response Rates by FDG Uptake on PET Scan | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. | One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan. | Posted | Number | participants | post-2 cycles of induction therapy (approximately 42 days from start of treatment) |
|
|
From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher.
Lab results, treatment records, and dictations reviewed weekly.
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 | Induction Chemo + RT + Cisplatin or Cetuximab | Induction chemotherapy: Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3. Post-Induction: Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W. | 19 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (ANC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphorus, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia: atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC-rectal abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with grade 4 neutrophils:lung-pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain:chest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism-vascular access device | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| INR | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash:acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash:penile (unconfirmed HSV) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dental:teeth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (ANC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage:nose | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| SGOT (AST) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| SGPT (ALT) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Edema:limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, high | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, low | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, low | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, high | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, low | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy:sensory (peripheral) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain:tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs (hiccups) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| GFR | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas R. Adkins | Washington University School of Medicine | 314-362-5654 | dadkins@dom.wustl.edu |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D000068818 | Cetuximab |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D055585 | Physical Phenomena |
Not provided
Not provided
|
|
|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|