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This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
The study treatment for this protocol is
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab, Gemcitabine, RT | Experimental | weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab/Gemcitabine | Drug | Once weekly Cetuximab, twice weekly Gemcitabine for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response of Tumor by RECIST 1.0 Criteria | Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. | one month post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed for Adverse Events | Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0 | Participants were followed during treatment and for 30 days after completion of treatment |
| Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Marc Pipas, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
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This was a single-institution study of weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with pancreatic ductal adenocarcinoma conducted at Dartmouth-Hitchcock.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab, Gemcitabine, Radiotherapy | Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab/Gemcitabine/Radiotherapy | weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Objective Response of Tumor by RECIST 1.0 Criteria | Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. | Completion of treatment | Posted | Number | participants | one month post-therapy |
|
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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 | Cetuximab/Gemcitabine/Radiotherapy | weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS Ischemia | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxtic reaction to erbitux | Immune system disorders | Systematic Assessment |
Our study suffers limitations common to single institution trials, namely small patient numbers and selection bias. Our cohort of subjects is too small to adequately assess the effect of tumor EGFR and KRAS status on outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Marc Pipas, MD | Dartmouth-Hitchcock | 603-650-9474 | J.Marc.Pipas@hitchcock.org |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Radiotherapy | Procedure | Daily radiotherapy for 28 days |
|
Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA). |
| 1 month after completion of treatment |
| Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. | Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment. | One month post-therapy |
| Disease-Free Survival After Therapy | Time to disease progression after therapy. | Five years post treatment |
| Overall Length of Survival After Therapy | Length of survival after therapy in all participants enrolled. | Five years post treatment |
| Pattern of Failure After Therapy | Local recurrence, distant recurrence, or both. | Five years post treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants Assessed for Adverse Events | Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0 | All participants were evaluated for toxicity. | Posted | Number | participants | Participants were followed during treatment and for 30 days after completion of treatment |
|
|
|
| Secondary | Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy | Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA). | Surviving participants who completed therapy and were determined to be resectable. | Posted | Number | participants | 1 month after completion of treatment |
|
|
|
| Secondary | Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. | Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment. | All EGFR (-) subjects who completed therapy were evaluated. | Posted | Number | percent | One month post-therapy |
|
|
|
| Secondary | Disease-Free Survival After Therapy | Time to disease progression after therapy. | All evaluable participants who completed treatment, and had confirmed progression of disease. | Posted | Median | Full Range | months | Five years post treatment |
|
|
|
| Secondary | Overall Length of Survival After Therapy | Length of survival after therapy in all participants enrolled. | All participants enrolled regardless of evaluability for primary outcome measure. | Posted | Median | Full Range | months | Five years post treatment |
|
|
|
| Secondary | Pattern of Failure After Therapy | Local recurrence, distant recurrence, or both. | All participants who completed treatment and underwent resection | Posted | Number | participants | Five years post treatment |
|
|
|
| 22 |
| 33 |
| 3 |
| Anemia | Investigations | Systematic Assessment |
|
| Gastrointestinal disorder - stent obstruction | Gastrointestinal disorders | Systematic Assessment | Stent obstruction is common in patients with pancreatic cancer. |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Gastritis/GI Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Hematoma subdural | Nervous system disorders | Systematic Assessment | This was related to a traumatic event, not to treatment. |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pain - gouty arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment | Of the 22 patients experiencing Grade 3 neutropenia, only one developed neutropenic fever requiring hospitalization. The other 21 were managed in an outpatient setting. |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
|
| number of ppts. without recurrence or unknown |
|