Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01280643
Collaborator
National Cancer Institute (NCI) (NIH)
3
1
9
50
0.1
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
-
To investigate the response rate associated with genotype/phenotype guided therapy using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
-
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.
-
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
3 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression, KRAS and BRAF Mutation Status, and ERCC1 Expression
Actual Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Jul 1, 2013
Actual Study Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: fluorouracil
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Biological: cetuximab
Given IV
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: 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. |
Drug: fluorouracil
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: oxaliplatin
Given IV
Other Names:
Biological: cetuximab
Given IV
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: Arm C Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. |
Drug: fluorouracil
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: irinotecan hydrochloride
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: Arm D Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. |
Drug: fluorouracil
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: oxaliplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: 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. |
Drug: irinotecan hydrochloride
Given IV
Other Names:
Biological: cetuximab
Given IV
Other Names:
Drug: capecitabine
Given PO
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: 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. |
Drug: oxaliplatin
Given IV
Other Names:
Biological: cetuximab
Given IV
Other Names:
Drug: capecitabine
Given PO
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: ARM G Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. |
Drug: irinotecan hydrochloride
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
Drug: capecitabine
Given PO
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: Arm H Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. |
Drug: oxaliplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
Drug: capecitabine
Given PO
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
| Experimental: Arm I Patients receive treatment as in Arm D. |
Drug: fluorouracil
Given IV
Other Names:
Drug: leucovorin calcium
Given IV
Other Names:
Drug: oxaliplatin
Given IV
Other Names:
Biological: bevacizumab
Given IV
Other Names:
Genetic: mutation analysis
Correlative studies
Genetic: gene expression analysis
Correlative studies
Other: laboratory biomarker analysis
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
Genetic: nucleic acid sequencing
Correlative studies
Other Names:
Genetic: protein expression analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Genetic: DNA analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects [Over 21 months]
Secondary Outcome Measures
- Best Overall Response Via RECIST [Over 21 months]
- Time to Failure of Treatment Strategy [Over 21 months]
- Progression-free Survival [Over 21 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must have histologically confirmed colon or rectal cancer that has metastasized; no biopsy of metastatic site(s) are required if presentation is consistent with metastatic disease
-
Available archived tissue block or slides from the primary colon or rectal cancer; approximately 25 slides from the primary tumor tissue are necessary for testing of all markers
-
Patients must have measurable disease by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with computed tomography (CT) scan or clinical exam with calipers; lymph nodes must be 15 mm in shortest dimension as measured on CT scan
-
Patients may not have received prior therapy for metastatic colorectal cancer; prior adjuvant therapy (including any of the study agents) is permitted if completed > 6 months from the initial detection of metastatic disease
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Absolute neutrophil count >= 1,500/mcL
-
Platelets >= 100,000/mcL
-
Total bilirubin =< 2 X institutional upper limit of normal (ULN)
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3 X institutional ULN or =< 5 X ULN if known liver metastases
-
Creatinine clearance >= 50 mL/min (as calculated by Cockroft and Gault formula)
-
Urine protein:creatinine (UPC) ratio < 1.0 at screening (as calculated from urine protein concentration and urine creatinine concentration); patients with a UPC ratio
= 1 will undergo a 24-hour urine collection, which must be adequate and demonstrate < 1 gram in order to participate
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
-
Patients who have had previous chemotherapy for metastatic colorectal cancer
-
Uncontrolled hypertension (>150/100 mmHg) despite a stable regimen of anti-hypertensive medication
-
History of cardiovascular disease, defined as previous myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure (New York Heart Association > Class II), clinically significant ventricular arrhythmia requiring medication, clinically significant peripheral vascular disease, or unstable angina within 6 months of study enrollment
-
Underlying neuropathy >= grade 2
-
Serious non-healing wounds, ulcers, or fistulas
-
Major surgery, open biopsy, or major traumatic injury within 28 days of registration, or anticipation of need for surgical procedure during course of study, and core biopsy or fine needle aspiration within 7 days of registration; closed biopsy or access port placement is acceptable
-
A history of thrombotic or hemorrhagic disorder; patients with elevated international normalized ratio (INR) (2.0 to 3.0) on stable doses of therapeutic anticoagulation are eligible
-
Untreated brain metastases; patients with treated brain metastases who have completed radiation therapy, are clinically and radiographically stable, and are off steroid therapy may be enrolled
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, oxaliplatin, capecitabine, or other agents used in the study
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
-
Pregnant women are excluded; breastfeeding should be discontinued if the mother is treated with chemotherapy
-
Human Immunodeficiency Virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
-
Patients must not have a history of another neoplasm < 5 years prior to enrollment, except for non-metastatic, non-melanoma skin cancer or carcinoma in situ of the cervix
-
Patients of child-bearing potential who are unwilling or unable to utilize contraceptive measures including barrier contraception
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111-2497 |
Sponsors and Collaborators
- Fox Chase Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Crystal Denlinger, Fox Chase Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01280643
Other Study ID Numbers:
- IRB 09-033
- NCI-2011-00046
First Posted:
Jan 21, 2011
Last Update Posted:
Mar 15, 2021
Last Verified:
Feb 1, 2021
Keywords provided by Fox Chase Cancer Center
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Period Title: Overall Study | |||||||||
| STARTED | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Total of all reporting groups |
| Overall Participants | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 3 |
| Age (Count of Participants) | ||||||||||
| <=18 years |
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
||||||
| Between 18 and 65 years |
1
Infinity
|
0
0%
|
1
100%
|
2
200%
|
||||||
| >=65 years |
0
NaN
|
1
100%
|
0
0%
|
1
100%
|
||||||
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
0
NaN
|
0
0%
|
0
0%
|
0
0%
|
||||||
| Male |
1
Infinity
|
1
100%
|
1
100%
|
3
300%
|
||||||
| Region of Enrollment (participants) [Number] | ||||||||||
| United States |
1
Infinity
|
1
100%
|
1
100%
|
3
300%
|
||||||
Outcome Measures
| Title | Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects |
|---|---|
| Description | |
| Time Frame | Over 21 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Too few enrolled participants for meaningful analysis |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Best Overall Response Via RECIST |
|---|---|
| Description | |
| Time Frame | Over 21 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Too few enrolled participants for meaningful analysis |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Time to Failure of Treatment Strategy |
|---|---|
| Description | |
| Time Frame | Over 21 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Too few enrolled participants for meaningful analysis |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | Progression-free Survival |
|---|---|
| Description | |
| Time Frame | Over 21 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Too few enrolled participants for meaningful analysis |
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | No patients accrued to arms A, E, F, G, H, I due to premature study closure resulting from slow accrual | |||||||||||||||||
| Arm/Group Title | Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I | |||||||||
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | |||||||||
All Cause Mortality |
||||||||||||||||||
| Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 1/1 (100%) | 0/1 (0%) | 0/1 (0%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Hospitalization - Chest pain | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Arm A | Arm B | Arm C | Arm D | Arm E | Arm F | ARM G | Arm H | Arm I | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Edema | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Diarrhea/Constipation | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Nausea | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Vomiting | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 3 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Epistaxis | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Dysguesia | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Hemorrhoids | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Hematochezia | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Dyspepsia | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Anorexia | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Pain | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Pharyngitis | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| General disorders | ||||||||||||||||||
| Fatigue | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Fever | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 1/1 (100%) | 4 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Sour stomach | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 3 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Flushed face | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Muscle cramps | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Myalgia | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Nervous system disorders | ||||||||||||||||||
| Sensory neuropathy | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Parasthesias | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Pain | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Restless legs | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Insomnia | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Twitching/restlessness | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| Anxiety | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Dyspnea | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Cough | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Alopecia | 0/0 (NaN) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
| Eczema | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 | 0/0 (NaN) | 0 |
Limitations/Caveats
Too few enrolled participants for meaningful analysis. Study closed prematurely due to slow accrual.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Crystal Denlinger |
|---|---|
| Organization | Fox Chase Cancer Center |
| Phone | 215-214-1676 |
| crystal.denlinger@fccc.edu |
Responsible Party:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01280643
Other Study ID Numbers:
- IRB 09-033
- NCI-2011-00046
First Posted:
Jan 21, 2011
Last Update Posted:
Mar 15, 2021
Last Verified:
Feb 1, 2021