Colorectal CancerPhase 2NCT00940316
Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
A Phase 2 study testing panitumumab, erlotinib hydrochloride and irinotecan hydrochloride in people with Colorectal Cancer, run by Northwestern University at 10 sites in United States.
Trial summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- panitumumab, erlotinib hydrochloride and irinotecan hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Jan 2010to Jan 2015
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Metastatic disease
- Biopsy of either the primary cancer or metastatic site required
- Tumor expressing wild-type Kras mutations
- Progressive disease within 3 months after treatment with first-line fluorouracil (5-FU) and oxaliplatin-based chemotherapy OR evidence of metastatic disease within 6 months of completing adjuvant therapy with 5-FU and oxaliplatin
- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 6 months
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN (or < 2 mg/dL)
- AST and/or ALT < 3 times ULN (< 5 times ULN with liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent malignancy requiring therapy except minor surgery for non-melanoma skin cancer removal
- No interstitial lung disease with symptoms (e.g., dyspnea or cough) including any of the following significant conditions:
- Parenchymal lung disease
- Metastatic disease
- Pulmonary infections
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior EGFR inhibitors, irinotecan hydrochloride, or other second-line chemotherapy regimens
- More than 4 weeks since prior radiotherapy
- No other concurrent investigational agents
- No other concurrent anticancer treatment modalities (e.g., radiotherapy)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, 60005
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611-3013
Hematology/Oncology Associates
Chicago, Illinois, 60611
The Jones Clinic
Germantown, Tennessee, 38138
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Virtua Memorial (Regional Cancer Care Associates of Mount Holly)
Mount Holly, New Jersey, 08060
Mercy Clinic Oncology and Hematology
Oklahoma City, Oklahoma, 73120-9309
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Hope Cancer Center
Terre Haute, Indiana, 47802
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Randomized Phase II Study of Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Irinotecan as Second Line Therapy in Patients With Metastatic Colorectal Cancer
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic colorectal cancer treated with erlotinib hydrochloride and panitumumab with versus without irinotecan hydrochloride as second-line therapy .
Secondary
- Determine time to disease progression and time to treatment failure in patients treated with these regimens.
- Determine the safety of these regimens in these patients.
- Determine the effect of these regimens on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition (exploratory).
- Determine the association between KRAS mutations and response to EGFR inhibition (exploratory).
OUTLINE: This is a multicenter study. Patients are stratified according to wild-type Kras tumors ( 6/6 UGT1A1 vs 6/7 UGT1A1), and are randomized to 1 of 2 treatment arms. Patients with wild-type Kras tumor 7/7 UGT1A1 receive treatment in arm III.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm I.
- Arm III: Patients receive erlotinib hydrochloride and panitumumab as in arm II. Skin biopsies and blood samples may be collected for further analysis.
After completion of study therapy, patients are followed every 6 weeks.
- Conditions
- Colorectal Cancer
- Being tested
- panitumumab, erlotinib hydrochloride, irinotecan hydrochloride
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV 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.
panitumumabBiological
Also called Vectibix
Given intravenously 6mg/kg every 2 weeks
erlotinib hydrochlorideDrug
Also called Tarceva
Given orally 150mg daily
Also called Camptosar, CPT-11
Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: panitumumab; Drug: erlotinib hydrochloride; Drug: irinotecan hydrochloride |
| Arm B: Erlotinib + Panitumumab | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. Receives: Biological: panitumumab; Drug: erlotinib hydrochloride; Drug: irinotecan hydrochloride |
| Arm C: Erlotinib + Panitumumab | Experimental | Patients receive erlotinib hydrochloride and panitumumab as in arm B. Receives: Biological: panitumumab; Drug: erlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions.
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Measured: At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.
Secondary outcomes (4)
Time to Disease Progression
Time to disease progression will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression . Time to disease progression will be defined as the time elapsed from the day of 1st study drug administration to the day disease progression is documented or death occurs and will .
Progressive Disease will be defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) : At least a 20% increase in the sum of the longest diameter (LD) of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks
Time to Treatment Failure
Time to treatment failure will be measured as the time elapsed from the day of first study drug administration to the date a subject stops all study drugs for any reason.
Measured: From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks
Toxicity of the Combination of Study Drugs
Data on the toxicity of the combination of study drugs is assessed by laboratory blood draws done on day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 3 and grade 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected using National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). AEs are graded as:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Measured: Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles.
Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition
Effect on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition. Skin biopsies will be performed at baseline (before the first days of treatment) and and at a time-point reflecting maximum rash intensity determined by a dermatologist.
Measured: At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study start18 Jan 2010
- Primary completionJan 2015
- Study completionJan 2015
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals, Amgen
- Responsible party
- Principal investigator, Al Benson, Northwestern University
- Investigators
- Al Benson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940316
- Sponsor's protocol ID
- NU 07I4
- Other IDs
- STU00004101, OSI 4263s
- Status last verified
- Apr 2019
- First submitted
- 15 Jul 2009
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Irinotecan as Second Line Therapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00940316
- Acronym / sponsor ID
- NU 07I4
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals, Amgen
- Study start
- 18 Jan 2010 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic colorectal cancer treated with erlotinib hydrochloride and panitumumab with versus without irinotecan hydrochloride as second-line therapy .
Secondary
- Determine time to disease progression and time to treatment failure in patients treated with these regimens.
- Determine the safety of these regimens in these patients.
- Determine the effect of these regimens on downstream targets of EGFR in skin rash associated with pharmacologic EGFR inhibition (exploratory).
- Determine the association between KRAS mutations and response to EGFR inhibition (exploratory).
OUTLINE: This is a multicenter study. Patients are stratified according to wild-type Kras tumors ( 6/6 UGT1A1 vs 6/7 UGT1A1), and are randomized to 1 of 2 treatment arms. Patients with wild-type Kras tumor 7/7 UGT1A1 receive treatment in arm III.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm I.
- Arm III: Patients receive erlotinib hydrochloride and panitumumab as in arm II. Skin biopsies and blood samples may be collected for further analysis.
After completion of study therapy, patients are followed every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Erlotinib + Panitumumab + Irinotecan | Experimental | Biological: panitumumab, Drug: erlotinib hydrochloride, Drug: irinotecan hydrochloridePatients receive oral erlotinib hydrochloride once daily on days 1-14, panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm B: Erlotinib + Panitumumab | Experimental | Biological: panitumumab, Drug: erlotinib hydrochloride, Drug: irinotecan hydrochloridePatients receive oral erlotinib hydrochloride once daily on days 1-14 and panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients receive irinotecan hydrochloride as in arm A. |
| Arm C: Erlotinib + Panitumumab | Experimental | Biological: panitumumab, Drug: erlotinib hydrochloridePatients receive erlotinib hydrochloride and panitumumab as in arm B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| panitumumabAlso: VectibixGiven intravenously 6mg/kg every 2 weeks | Biological | Arm A: Erlotinib + Panitumumab + Irinotecan, Arm B: Erlotinib + Panitumumab, Arm C: Erlotinib + Panitumumab |
| erlotinib hydrochlorideAlso: TarcevaGiven orally 150mg daily | Drug | Arm A: Erlotinib + Panitumumab + Irinotecan, Arm B: Erlotinib + Panitumumab, Arm C: Erlotinib + Panitumumab |
| irinotecan hydrochlorideAlso: Camptosar, CPT-11Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype | Drug | Arm A: Erlotinib + Panitumumab + Irinotecan, Arm B: Erlotinib + Panitumumab |
Primary outcome
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)
Time frame: At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD)of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions,taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
4 secondary outcomes
Time to Disease Progression
Time frame: At baseline and every 8 weeks during treatment until disease progression and for a maximum of 51 cycles where 1 cycle = 2 weeks
Time to Treatment Failure
Time frame: From first day of study drug treatment until the date of stopping all study drugs for any reason for a maximum of 51 cycles where 1 cycle=2weeks
Toxicity of the Combination of Study Drugs
Time frame: Day 1 of every 2 week treatment cycle while on study treatment and 30 days after the last treatment for a maximum of 51 cycles.
Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition
Time frame: At baseline and at a time-point reflecting maximum rash intensity during treatment, at a maximum of 51 cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- 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.
Al Benson, MD principal investigator
Northwestern University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panitumumab, erlotinib hydrochloride and irinotecan hydrochloride in people with Colorectal Cancer, run by Northwestern University at 10 sites 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?
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: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2019). 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?
Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) (time frame: At baseline and every 8 weeks during treatment until progressive disease for maximum of 51 cycles where 1 cycle = 2 weeks.). 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 7 May 2019.