Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00046 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, capecitabine, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab and cetuximab, 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. Giving combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells.
PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase, ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens
PRIMARY OBJECTIVES:
I. To evaluate the feasibility, as defined by completion of three specific marker assays and generation of clinically meaningful endpoints, of selecting treatment regimen components based on biologic tumor characteristics in chemotherapy-naïve patients with metastatic colorectal cancer.
SECONDARY OBJECTIVES:
I. To investigate the response rate associated with genotype/phenotype guided therapy using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
II. To investigate the time to failure of treatment strategy associated with genotype/phenotype guided therapy, defined as the time from initiation of investigational treatment strategy until death, disease progression, initiation of a new therapeutic agent, or disease progression while on a partial or complete treatment holiday.
III. To investigate the progression-free survival associated with genotype/phenotype guided therapy, defined as the time from enrollment to time of progression of disease or death.
OUTLINE: Patients are assigned to treatment groups based on marker assay results.
ARM A: TP-/uncertain, KRAS and BRAF wild-type, ERCC1 high ARM B: TP-/uncertain, KRAS and BRAF wild-type, ERCC1 low/uncertain ARM C: TP-/uncertain, KRAS or BRAF mutant/uncertain, ERCC1 high ARM D: TP-/uncertain, KRAS or BRAF mutant/uncertain, ERCC1 low/uncertain ARM E: TP+, KRAS and BRAF wild-type, ERCC1 high ARM F: TP+, KRAS and BRAF wild-type, ERCC1 low/uncertain ARM G: TP+, KRAS or BRAF mutant/uncertain, ERCC1 high ARM H: TP+, KRAS or BRAF mutant/uncertain, ERCC1 low/uncertain ARM I: TP uninterpretable, KRAS or BRAF uninterpretable, ERCC1 uninterpretable
KRAS testing is standard of care in patients with metastatic colorectal cancer; tymidine phosphorylase, ERCC1 and BRAF testing assays are still experimental.
Courses in arms A-D and arm I repeat every 28 days and courses in arms E-H repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. |
|
| Arm B | Experimental | Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. |
|
| Arm C | Experimental | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects | Over 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Via RECIST | Over 21 months | |
| Time to Failure of Treatment Strategy | Over 21 months | |
| Progression-free Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Crystal Denlinger | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arm D | Experimental | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. |
|
| Arm E | Experimental | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. |
|
| Arm F | Experimental | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. |
|
| ARM G | Experimental | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. |
|
| Arm H | Experimental | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. |
|
| Arm I | Experimental | Patients receive treatment as in Arm D. |
|
| leucovorin calcium | Drug | Given IV |
|
|
| oxaliplatin | Drug | Given IV |
|
|
| irinotecan hydrochloride | Drug | Given IV |
|
|
| bevacizumab | Biological | Given IV |
|
|
| cetuximab | Biological | Given IV |
|
|
| capecitabine | Drug | Given PO |
|
|
| mutation analysis | Genetic | Correlative studies |
|
| gene expression analysis | Genetic | Correlative studies |
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| immunohistochemistry staining method | Other | Correlative studies |
|
|
| nucleic acid sequencing | Genetic | Correlative studies |
|
|
| protein expression analysis | Genetic | Correlative studies |
|
| polymerase chain reaction | Genetic | Correlative studies |
|
|
| DNA analysis | Genetic | Correlative studies |
|
| Over 21 months |
| FG001 | Arm B | Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| FG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Study closed prematurely due to poor accrual
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG001 | Arm B | Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| BG009 | 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 |
| ||||||||||||||||
| 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 | Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects | Too few enrolled participants for meaningful analysis | Posted | Over 21 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response Via RECIST | Too few enrolled participants for meaningful analysis | Posted | Over 21 months |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Failure of Treatment Strategy | Too few enrolled participants for meaningful analysis | Posted | Over 21 months |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Too few enrolled participants for meaningful analysis | Posted | Over 21 months |
|
Not provided
No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual
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 | Arm A | Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Arm B | Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV cetuximab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 1 | 1 | 1 | 1 | 1 |
| EG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 1 | 1 | 0 | 1 | 1 | 1 |
| EG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| EG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Diarrhea/Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Epistaxis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysguesia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sour stomach | General disorders | Systematic Assessment |
| ||
| Hematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema | Cardiac disorders | Systematic Assessment | Bilateral hands |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Parasthesias | Nervous system disorders | Systematic Assessment | In hands and feet |
| |
| Pain | Nervous system disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Restless legs | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Muscle cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Cramping in legs |
| |
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Flushed face | General disorders | Systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain | Gastrointestinal disorders | Systematic Assessment | Jaw pain |
| |
| Pharyngitis | Gastrointestinal disorders | Systematic Assessment | Scratchy throat |
| |
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Twitching/restlessness | Nervous system disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | At injection site |
| |
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Too few enrolled participants for meaningful analysis. Study closed prematurely due to slow accrual.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Crystal Denlinger | Fox Chase Cancer Center | 215-214-1676 | crystal.denlinger@fccc.edu |
| 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 |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D000068258 | Bevacizumab |
| D000068818 | Cetuximab |
| D000069287 | Capecitabine |
| D020869 | Gene Expression Profiling |
| D007150 | Immunohistochemistry |
| D001483 | Base Sequence |
| D016133 | Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D021141 | Nucleic Acid Amplification Techniques |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
|
| OG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
|
| OG002 | Arm C | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV irinotecan hydrochloride: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG003 | Arm D | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG004 | Arm E | Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. irinotecan hydrochloride: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG005 | Arm F | Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8. oxaliplatin: Given IV cetuximab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG006 | ARM G | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. irinotecan hydrochloride: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG007 | Arm H | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. oxaliplatin: Given IV bevacizumab: Given IV capecitabine: Given PO mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
| OG008 | Arm I | Patients receive treatment as in Arm D. fluorouracil: Given IV leucovorin calcium: Given IV oxaliplatin: Given IV bevacizumab: Given IV mutation analysis: Correlative studies gene expression analysis: Correlative studies laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies nucleic acid sequencing: Correlative studies protein expression analysis: Correlative studies polymerase chain reaction: Correlative studies DNA analysis: Correlative studies |
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