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| ID | Type | Description | Link |
|---|---|---|---|
| STU00004101 | Other Identifier | Northwestern University IRB | |
| OSI 4263s | Other Identifier | OSI Pharmaceuticals, Inc |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| OSI Pharmaceuticals | INDUSTRY |
| Amgen | INDUSTRY |
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RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to wild-type Kras tumors ( 6/6 UGT1A1 vs 6/7 UGT1A1), and are randomized to 1 of 2 treatment arms. Patients with wild-type Kras tumor 7/7 UGT1A1 receive treatment in arm III.
After completion of study therapy, patients are followed every 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Arm B: Erlotinib + Panitumumab | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. |
|
| Arm C: Erlotinib + Panitumumab | Experimental | Patients receive erlotinib hydrochloride and panitumumab as in arm B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panitumumab | Biological | Given intravenously 6mg/kg every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) | Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started | At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will . Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
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DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Metastatic disease
Tumor expressing wild-type Kras mutations
Progressive disease within 3 months after treatment with first-line fluorouracil (5-FU) and oxaliplatin-based chemotherapy OR evidence of metastatic disease within 6 months of completing adjuvant therapy with 5-FU and oxaliplatin
Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 6 months
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Creatinine < 1.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN (or < 2 mg/dL)
AST and/or ALT < 3 times ULN (< 5 times ULN with liver metastases)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent malignancy requiring therapy except minor surgery for non-melanoma skin cancer removal
No interstitial lung disease with symptoms (e.g., dyspnea or cough) including any of the following significant conditions:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Al Benson, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Care & Hematology Specialists of Chicagoland | Arlington Heights | Illinois | 60005 | United States | ||
Subjects with either 6/6 UGT1A1 genotype or 6/7 UGT1A1 genotype will be randomized into either Arm A and Arm B. Subjects with 7/7 UGT1A1 genotype enrolled in Arm C.
The study opened for accrual on July 9, 2009 with an accrual goal of up to 96 patients. The study was designed to enroll 13 patients on each arm and do an interim efficacy assessment. Accrual was suspended on March 31 2015 fand closed permanently on April 13, 2015 with 28 patients enrolled on the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Erlotinib + Panitumumab + Irinotecan | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Reached First Response at 8 Weeks |
|
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| erlotinib hydrochloride | Drug | Given orally 150mg daily |
|
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| irinotecan hydrochloride | Drug | Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
|
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| At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks |
| Time to Treatment Failure | Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason. | From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks |
| Toxicity of the Combination of Study Drugs | Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles. |
| Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition | Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist. | At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles. |
| Northwestern University, Northwestern Medical Faculty Foundation |
| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| Hematology/Oncology Associates | Chicago | Illinois | 60611 | United States |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Hope Cancer Center | Terre Haute | Indiana | 47802 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Virtua Memorial (Regional Cancer Care Associates of Mount Holly) | Mount Holly | New Jersey | 08060 | United States |
| Mercy Clinic Oncology and Hematology | Oklahoma City | Oklahoma | 73120-9309 | United States |
| The Jones Clinic | Germantown | Tennessee | 38138 | United States |
| FG001 | Arm B: Erlotinib + Panitumumab | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
| FG002 | Arm C: Erlotinib + Panitumumab | Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily |
| COMPLETED |
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| NOT COMPLETED |
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| Moved on to be Treated Cycle 5 |
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| Treated After Cycle 5 |
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| Crossed Over to Arm A After Progression |
|
| Follow up Every 3 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Erlotinib + Panitumumab + Irinotecan | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
| BG001 | Arm B: Erlotinib + Panitumumab | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype |
| BG002 | Arm C: Erlotinib + Panitumumab | Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily |
| BG003 | Total | Total of all reporting groups |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| UGT1A1 genotyping 6/6 | Count of Participants | Participants | No |
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| UGT1A1 genotyping 6/7 | Count of Participants | Participants | No |
| |||||||||||||||
| UGT1A1 genotyping 7/7 | Count of Participants | Participants | No |
|
| 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 | Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) | Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started | Posted | Count of Participants | Participants | At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks. |
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| Secondary | Time to Disease Progression | Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will . Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | All patient data analyzed reported together regardless of arm allocation. Data not collected and analyzed for this outcome measure. | Posted | At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks |
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| Secondary | Time to Treatment Failure | Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason. | Data was not collected and analyzed for this outcome measure | Posted | From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks |
|
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| Secondary | Toxicity of the Combination of Study Drugs | Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | Posted | Number | participants | No | Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition | Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist. | All patient data analyzed reported together regardless of arm allocation.This outcome measure was based on optional biopsies that patients were required to consent to. Data was not collected or analyzed for this outcome measure. | Posted | At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles. |
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| Post-Hoc | Median Overall Survival | Median Overall Survival (OS) is measured from treatment initiation until death due to any cause. | Posted | Median | 95% Confidence Interval | Months | From the time of first treatment to death |
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| Post-Hoc | Progression Free Survival (PFS) | Progression free survival will be measured every 8 weeks during treatment by CT or MRI scans. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | 95% Confidence Interval | Months | At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks |
|
Adverse events (AE) for the study were collected over a 5 year period. AEs were collected for each patient whilst on treatment and for 30 days post last treatment for a maximum of up to 51 cycles (longest number of cycles any one patient received treatment)
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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 A: Erlotinib + Panitumumab + Irinotecan | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype | 11 | 13 | 3 | 13 | 13 | 13 |
| EG001 | Arm B: Erlotinib + Panitumumab | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype | 10 | 10 | 4 | 10 | 10 | 10 |
| EG002 | Arm C: Erlotinib + Panitumumab | Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily | 1 | 2 | 1 | 2 | 2 | 2 |
| EG003 | Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle. | 3 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted for diarrhea but also had fatigue, neutropenic fever, nausea and vomiting during the hospital admission. |
|
| Small bowel obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patient also experienced decreased white blood cell count |
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| Death NOS- progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | Patient also experienced drug induced pneumonitis during this hospital admission |
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| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Partial Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patient also experienced anemia and colonic fistula during this hospital admission. |
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| Neutropenic fever | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Patient also experienced diarrhea, sepsis and rash during this hospital admission |
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| Urinary Track infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Patient also experienced anemia during this hospital admission |
|
| Bronchitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Patient also experiences esophagitis during this hospital admission |
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| Altered mental status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing: patients without baseline audiogram and not enrolled in a monitoring | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Otitis, external ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (Anemia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (neutropenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total white blood cells) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets (thrombocytopenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated BUN | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
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| International Normalized Ratio of prothrombin time (INR) | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Cheilitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss (alopecia) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Rash: Hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Paronychia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Fungal infection beneath left breast | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pseudomonas | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Extensive growth of eyelashes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Scalp rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Face rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Glucose intolerance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Distension/bloating of abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Mucositis/stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Heartburn (dyspepsia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Retal burning | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Colon cancer with liver metastasis and likely bone metastasis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nosebleed | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection in pelvis (with normal ANC or grade 1 or 2 neutrophils) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection in upper airway (with normal ANC or Grade 1 or 2 neutrophils) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection in abdomen (with normal ANC or Grade 1 or 2 neutrophils) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection in urinary tract (unknown ANC) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Paronychia (infection with grade 3 or 4 neutrophils) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Skin infection (Cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Ear infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Pseudomonas Bactermia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Escherichia coli | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Edema - limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Alkaline phosphatase increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT increase (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| AST increase (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Bilirubin increase (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Creatinine increase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatine phosphokinase (CPK) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, se high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sensory Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fainting (syncope episode) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neck stiffness | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle cramps | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity/limb pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectum pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flank pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain in throat | Respiratory, thoracic and mediastinal disorders | 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 |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye lesion | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cloudy vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eythema/conjunctive | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urine color change | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased GFR | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral dysesthesia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
Sponsor did not renew contract and only 28 patients of the anticipated 96 were enrolled and treated on the study.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Al Benson | Northwestern University | (312) 695-0184 | albenson@nm.org |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D000069347 | Erlotinib Hydrochloride |
| D000077146 | Irinotecan |
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Stable disease |
|
|
| OG002 | Arm C: Erlotinib + Panitumumab | Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily |
| OG003 | Arm B Cross Over - Erlotinib + Panitumumab + Irinotecan | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily irinotecan hydrochloride: Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype After progression patients cross over to Arm A and Irinotecan is added. irinotecan hydrochloride IV over 90 minutes on day 1 or a 14 day cycle. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| OG002 | Arm C: Erlotinib + Panitumumab | Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily |
|
|
| OG002 | Arm C: Erlotinib + Panitumumab | Arm C - Patients receive erlotinib hydrochloride and panitumumab as in arm B. panitumumab: Given intravenously 6mg/kg every 2 weeks erlotinib hydrochloride: Given orally 150mg daily |
|
|