Metastatic Colorectal CancerNCT01280643
Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
A study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Metastatic Colorectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- fluorouracil, leucovorin calcium and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression, KRAS and BRAF Mutation Status, and ERCC1 Expression
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
Read the 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.
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- fluorouracil, leucovorin calcium, oxaliplatin, irinotecan hydrochloride, bevacizumab
- Keywords
- stage IVA colon cancer, stage IVA rectal cancer, stage IVB colon cancer, stage IVB rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
Also called CF, CFR, LV
Given IV
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
Also called Campto, Camptosar, CPT-11, irinotecan
Given IV
bevacizumabBiological
Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Given IV
cetuximabBiological
Also called C225, C225 monoclonal antibody, IMC-C225, MOAB C225
Given IV
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given PO
mutation analysisGenetic
Correlative studies
gene expression analysisGenetic
Correlative studies
laboratory biomarker analysisOther
Correlative studies
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative studies
nucleic acid sequencingGenetic
Also called Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing
Correlative studies
protein expression analysisGenetic
Correlative studies
polymerase chain reactionGenetic
Also called PCR
Correlative studies
DNA analysisGenetic
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: irinotecan hydrochloride; Biological: cetuximab; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| 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. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Biological: cetuximab; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| Arm C | Experimental | Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: irinotecan hydrochloride; Biological: bevacizumab; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| Arm D | Experimental | Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Biological: bevacizumab; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| 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. Receives: Drug: irinotecan hydrochloride; Biological: cetuximab; Drug: capecitabine; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| 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. Receives: Drug: oxaliplatin; Biological: cetuximab; Drug: capecitabine; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| ARM G | Experimental | Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. Receives: Drug: irinotecan hydrochloride; Biological: bevacizumab; Drug: capecitabine; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| Arm H | Experimental | Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. Receives: Drug: oxaliplatin; Biological: bevacizumab; Drug: capecitabine; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
| Arm I | Experimental | Patients receive treatment as in Arm D. Receives: Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Biological: bevacizumab; Genetic: mutation analysis; Genetic: gene expression analysis; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: nucleic acid sequencing; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects
Measured: Over 21 months
Secondary outcomes (3)
Best Overall Response Via RECIST
Measured: Over 21 months
Time to Failure of Treatment Strategy
Measured: Over 21 months
Progression-free Survival
Measured: Over 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2013
- Study completionMay 2014
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Crystal Denlinger, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280643
- Sponsor's protocol ID
- IRB 09-033
- Other IDs
- NCI-2011-00046
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2011
- Last updated
- 15 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression, KRAS and BRAF Mutation Status, and ERCC1 Expression
- ClinicalTrials.gov ID
- NCT01280643
- Acronym / sponsor ID
- IRB 09-033
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- stage IVA colon cancer, stage IVA rectal cancer, stage IVB colon cancer, stage IVB rectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2010 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Drug: irinotecan hydrochloride, Biological: cetuximab, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients 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 | Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Biological: cetuximab, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients 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 | Drug: fluorouracil, Drug: leucovorin calcium, Drug: irinotecan hydrochloride, Biological: bevacizumab, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15. |
| Arm D | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Biological: bevacizumab, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15. |
| Arm E | Experimental | Drug: irinotecan hydrochloride, Biological: cetuximab, Drug: capecitabine, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients 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 | Drug: oxaliplatin, Biological: cetuximab, Drug: capecitabine, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients 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 | Drug: irinotecan hydrochloride, Biological: bevacizumab, Drug: capecitabine, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1. |
| Arm H | Experimental | Drug: oxaliplatin, Biological: bevacizumab, Drug: capecitabine, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1. |
| Arm I | Experimental | Drug: fluorouracil, Drug: leucovorin calcium, Drug: oxaliplatin, Biological: bevacizumab, Genetic: mutation analysis, Genetic: gene expression analysis, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: nucleic acid sequencing, Genetic: protein expression analysis, Genetic: polymerase chain reaction, Genetic: DNA analysisPatients receive treatment as in Arm D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUGiven IV | Drug | Arm A, Arm B, Arm C, Arm D, Arm I |
| leucovorin calciumAlso: CF, CFR, LVGiven IV | Drug | Arm A, Arm B, Arm C, Arm D, Arm I |
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Arm B, Arm D, Arm F, Arm H, Arm I |
| irinotecan hydrochlorideAlso: Campto, Camptosar, CPT-11, irinotecanGiven IV | Drug | ARM G, Arm A, Arm C, Arm E |
| bevacizumabAlso: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGFGiven IV | Biological | ARM G, Arm C, Arm D, Arm H, Arm I |
| cetuximabAlso: C225, C225 monoclonal antibody, IMC-C225, MOAB C225Given IV | Biological | Arm A, Arm B, Arm E, Arm F |
| capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven PO | Drug | ARM G, Arm E, Arm F, Arm H |
| mutation analysisCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| gene expression analysisCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| laboratory biomarker analysisCorrelative studies | Other | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative studies | Other | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| nucleic acid sequencingAlso: Gene Sequencing, Molecular Biology, Nucleic Acid SequencingCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| protein expression analysisCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| polymerase chain reactionAlso: PCRCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
| DNA analysisCorrelative studies | Genetic | ARM G, Arm A, Arm B, Arm C, Arm D, Arm E, Arm F, Arm H, Arm I |
Primary outcome
Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects
Time frame: Over 21 months
3 secondary outcomes
Best Overall Response Via RECIST
Time frame: Over 21 months
Time to Failure of Treatment Strategy
Time frame: Over 21 months
Progression-free Survival
Time frame: Over 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Denlinger principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorouracil, leucovorin calcium and oxaliplatin in people with Metastatic Colorectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects (time frame: Over 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.