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The purpose of this study is to collect data and evaluate how the tumor is broken down in response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans, toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.
Primary Endpoint
To compare the SUV (standardized uptake value) at up to three target tumor sites as assessed by FDG-PET/CT of eligible patients at baseline and then after eight weeks of treatment with cetuximab.
Secondary Endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1) Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50. Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion) Cetuximab 250 mg/m2 IV over 1 hour on Day 57 Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG-PET/CT | Procedure |
| ||
| Cetuximab |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT | FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response. | Baseline and after 8 weeks of treatment |
| SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab. | Eight weeks of treatment is equal to one cycle of treatment. FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response. | Baseline and after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT | Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)-complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)-20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)-one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)-not qualifying as CMR, PMR, or PMD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Adkins, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | United States | |||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14974761 | Background | Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8. | |
| 12860957 | Background | Mendelsohn J, Baselga J. Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J Clin Oncol. 2003 Jul 15;21(14):2787-99. doi: 10.1200/JCO.2003.01.504. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Recruitment was open from 06/03/08-10/17/11 at the Siteman Cancer Center (a medical clinic).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Cetuximab) | Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1) Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50. Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion) Cetuximab 250 mg/m2 IV over 1 hour on Day 57 Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| After 8 weeks of treatment |
| Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan | Definitions of anatomic response by RECIST for CT scan included: complete response(CR)-disappearance of all target and non-target lesions and no new lesions; partial response(PR)-at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)-at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions. | After 8 weeks of treatment |
| Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination | A generalization of McNemar's test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT. | After 8 weeks of treatment |
| Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination | Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions. | After 8 weeks of treatment |
| Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination | Every 8 weeks until disease progression (up to 1 year) |
| Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy | Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT. | Every 8 weeks until disease progression (up to 1 year) |
| Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy | Every 8 weeks until death (approximately 5 years) |
| Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy | Every 8 weeks until death (approximately 5 years) |
| Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck | 30 days after end of study treatment (approximately 1 year after start of treatment) |
| St Louis |
| Missouri |
| 63110 |
| United States |
| 8410112 | Background | Dassonville O, Formento JL, Francoual M, Ramaioli A, Santini J, Schneider M, Demard F, Milano G. Expression of epidermal growth factor receptor and survival in upper aerodigestive tract cancer. J Clin Oncol. 1993 Oct;11(10):1873-8. doi: 10.1200/JCO.1993.11.10.1873. |
| 12499279 | Background | Ang KK, Berkey BA, Tu X, Zhang HZ, Katz R, Hammond EH, Fu KK, Milas L. Impact of epidermal growth factor receptor expression on survival and pattern of relapse in patients with advanced head and neck carcinoma. Cancer Res. 2002 Dec 15;62(24):7350-6. |
| 15289342 | Background | Huang S, Armstrong EA, Benavente S, Chinnaiyan P, Harari PM. Dual-agent molecular targeting of the epidermal growth factor receptor (EGFR): combining anti-EGFR antibody with tyrosine kinase inhibitor. Cancer Res. 2004 Aug 1;64(15):5355-62. doi: 10.1158/0008-5472.CAN-04-0562. |
| 12743152 | Background | Cohen EE, Rosen F, Stadler WM, Recant W, Stenson K, Huo D, Vokes EE. Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol. 2003 May 15;21(10):1980-7. doi: 10.1200/JCO.2003.10.051. |
| 16467544 | Background | Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422. |
| 16009950 | Background | Baselga J, Trigo JM, Bourhis J, Tortochaux J, Cortes-Funes H, Hitt R, Gascon P, Amellal N, Harstrick A, Eckardt A. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol. 2005 Aug 20;23(24):5568-77. doi: 10.1200/JCO.2005.07.119. Epub 2005 Jul 11. |
| Background | J. Trigo et al., Cetuximab monotherapy is active in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck: Results of a phase II study (abstract). Proc Am Soc Clin Oncol 23 (2004), p. 487a. |
| 14574516 | Background | Vermeersch H, Loose D, Ham H, Otte A, Van de Wiele C. Nuclear medicine imaging for the assessment of primary and recurrent head and neck carcinoma using routinely available tracers. Eur J Nucl Med Mol Imaging. 2003 Dec;30(12):1689-700. doi: 10.1007/s00259-003-1345-4. Epub 2003 Oct 22. |
| 15514377 | Background | Antoch G, Saoudi N, Kuehl H, Dahmen G, Mueller SP, Beyer T, Bockisch A, Debatin JF, Freudenberg LS. Accuracy of whole-body dual-modality fluorine-18-2-fluoro-2-deoxy-D-glucose positron emission tomography and computed tomography (FDG-PET/CT) for tumor staging in solid tumors: comparison with CT and PET. J Clin Oncol. 2004 Nov 1;22(21):4357-68. doi: 10.1200/JCO.2004.08.120. |
| 15611393 | Background | Schwartz DL, Rajendran J, Yueh B, Coltrera MD, Leblanc M, Eary J, Krohn K. FDG-PET prediction of head and neck squamous cell cancer outcomes. Arch Otolaryngol Head Neck Surg. 2004 Dec;130(12):1361-7. doi: 10.1001/archotol.130.12.1361. |
| 9430467 | Background | Minn H, Lapela M, Klemi PJ, Grenman R, Leskinen S, Lindholm P, Bergman J, Eronen E, Haaparanta M, Joensuu H. Prediction of survival with fluorine-18-fluoro-deoxyglucose and PET in head and neck cancer. J Nucl Med. 1997 Dec;38(12):1907-11. |
| 11891942 | Background | Brun E, Kjellen E, Tennvall J, Ohlsson T, Sandell A, Perfekt R, Perfekt R, Wennerberg J, Strand SE. FDG PET studies during treatment: prediction of therapy outcome in head and neck squamous cell carcinoma. Head Neck. 2002 Feb;24(2):127-35. doi: 10.1002/hed.10037. |
| 11408502 | Background | Weber WA, Ott K, Becker K, Dittler HJ, Helmberger H, Avril NE, Meisetschlager G, Busch R, Siewert JR, Schwaiger M, Fink U. Prediction of response to preoperative chemotherapy in adenocarcinomas of the esophagogastric junction by metabolic imaging. J Clin Oncol. 2001 Jun 15;19(12):3058-65. doi: 10.1200/JCO.2001.19.12.3058. |
| 12419428 | Background | Choi NC, Fischman AJ, Niemierko A, Ryu JS, Lynch T, Wain J, Wright C, Fidias P, Mathisen D. Dose-response relationship between probability of pathologic tumor control and glucose metabolic rate measured with FDG PET after preoperative chemoradiotherapy in locally advanced non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2002 Nov 15;54(4):1024-35. doi: 10.1016/s0360-3016(02)03038-9. |
| 12163626 | Background | Kostakoglu L, Coleman M, Leonard JP, Kuji I, Zoe H, Goldsmith SJ. PET predicts prognosis after 1 cycle of chemotherapy in aggressive lymphoma and Hodgkin's disease. J Nucl Med. 2002 Aug;43(8):1018-27. |
| Background | M. Beeram et al., Durable disease stabilization and antitumor activity with OSI-774 in renal cell carcinoma: A phase II, pharmacokinetic (PK) and biological correlative study with FDG-PET imaging. J Clinical Oncology 22 (2004), pp. 3050. |
| Background | T. Trarbach et al., A randomized phase I study of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody EMD 72000 in subjects with advanced gastrointestinal cancers. J Clinical Oncology 22 (2004), pp. 3018. |
| 16293972 | Background | Goldstein D, Tan BS, Rossleigh M, Haindl W, Walker B, Dixon J. Gastrointestinal stromal tumours: correlation of F-FDG gamma camera-based coincidence positron emission tomography with CT for the assessment of treatment response--an AGITG study. Oncology. 2005;69(4):326-32. doi: 10.1159/000089765. Epub 2005 Nov 16. |
| 15001674 | Background | Antoch G, Kanja J, Bauer S, Kuehl H, Renzing-Koehler K, Schuette J, Bockisch A, Debatin JF, Freudenberg LS. Comparison of PET, CT, and dual-modality PET/CT imaging for monitoring of imatinib (STI571) therapy in patients with gastrointestinal stromal tumors. J Nucl Med. 2004 Mar;45(3):357-65. |
| 14734662 | Background | Gayed I, Vu T, Iyer R, Johnson M, Macapinlac H, Swanston N, Podoloff D. The role of 18F-FDG PET in staging and early prediction of response to therapy of recurrent gastrointestinal stromal tumors. J Nucl Med. 2004 Jan;45(1):17-21. |
| Background | Bristol-Meyer-Squibb, Product Information for Erbitux, 2004. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline participants are based on the number of evaluable patients. 15 out of the 42 enrolled patients were not considered evaluable for analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Cetuximab) | Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1) Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50. Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion) Cetuximab 250 mg/m2 IV over 1 hour on Day 57 Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease |
| 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 | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 Fully active able to carry on all predisease performance without restriction
| Number | participants |
| ||||||||||||||||||||||
| Smoking history | Number | participants |
| |||||||||||||||||||||||
| Primary Tumor Site | Number | participants |
| |||||||||||||||||||||||
| Prior Cetuximab Exposure | 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 | Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT | FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response. | Posted | Mean | Full Range | percentage of change | Baseline and after 8 weeks of treatment |
|
|
| ||||||||||||||||||||||||||
| Primary | SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab. | Eight weeks of treatment is equal to one cycle of treatment. FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response. | Posted | Mean | 95% Confidence Interval | SUVmax | Baseline and after 8 weeks of treatment |
| ||||||||||||||||||||||||||||
| Secondary | Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT | Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)-complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)-20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)-one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)-not qualifying as CMR, PMR, or PMD. | Posted | Number | participants | After 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan | Definitions of anatomic response by RECIST for CT scan included: complete response(CR)-disappearance of all target and non-target lesions and no new lesions; partial response(PR)-at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)-at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions. | Posted | Number | participants | After 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||
| Secondary | Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination | A generalization of McNemar's test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT. | Posted | Number | participants | After 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||
| Secondary | Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination | Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions. | Posted | Number | participants | After 8 weeks of treatment |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination | Posted | Number | participants | Every 8 weeks until disease progression (up to 1 year) |
|
| |||||||||||||||||||||||||||||
| Secondary | Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy | Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT. | Posted | Median | 95% Confidence Interval | days | Every 8 weeks until disease progression (up to 1 year) |
|
| |||||||||||||||||||||||||||
| Secondary | Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy | The small dataset precluded an adequate analysis of overall survival relationships due to varying co-variates such as post-progression therapies, ECOG PS, co-morbidities. | Posted | Every 8 weeks until death (approximately 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy | This was not analyzed due to the lack of evidence-based medicine showing an overall survival benefit of cetuximab monotherapy in this type of cancer. | Posted | Every 8 weeks until death (approximately 5 years) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck | Posted | Number | participants | 30 days after end of study treatment (approximately 1 year after start of treatment) |
|
|
Not provided
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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 | Arm 1 (Cetuximab) | Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1) Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50. Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion) Cetuximab 250 mg/m2 IV over 1 hour on Day 57 Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease | 7 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Grade 4 |
|
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment | Grade 4 |
|
| Brachial plexopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Grade 4 Due to radiographically proven tumor progression |
|
| Bronchospasm/Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 5 Chronic obstructive pulmonary disease (COPD) |
|
| Death - Disease Progression | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 5 |
|
| Infection lung - pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 5 |
|
| Lymphocytes (decreased) | Investigations | CTCAE (3.0) | Systematic Assessment | Grade 4 Occurred in the setting of concurrent administration of dexamethasone for head and neck lymph edema occurring due to the patient's disease. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium (high) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose (high) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (low) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage: Tumor Site | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| INR (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection normal ANC - cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection normal ANC - skin | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection normal ANC - upper respiratory | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection skin - ungual | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphocytes (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium (high) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT (high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - musculoskeletal - neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets (low) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rach - acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash - trach site | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SGOT (AST - high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| SGPT (ALT-high) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium (high) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium (low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium (high) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - tumor | 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 |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal 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 |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Performance Status 2 |
|
| Larynx |
|
| Hypopharynx |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
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