Recurrent Non-small Cell Lung CancerPhase 1/2NCT00778167
Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 1/2 study testing cixutumumab, erlotinib hydrochloride and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIA Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- What is being tested?
- cixutumumab, erlotinib hydrochloride and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to May 2012
- Phase
- Phase 1/2
- 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
Who may be able to join
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA, IIIB, or IV disease
- Mixed histology permitted provided small-cell elements are not present
- Measurable disease, defined as ≥ 1unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Must have failed ≥ 1 platinum-containing chemotherapy regimen
- CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks
Show all 35Show fewer
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 3 months
- Leukocytes ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 100,000/mm³
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Fasting serum glucose < 120 mg/dL OR normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A122 or erlotinib hydrochloride
- No poorly controlled diabetes mellitus
- Patients with a history of diabetes mellitus are eligible, provided their blood glucose is within normal range at screening and they are on a stable dietary or therapeutic regimen for this condition
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- No inability to take oral medications or, in the investigator's opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications
- No prior or concurrent exposure to other EGFR or IGFR inhibitors
- Recovered from all prior therapy with acute effects resolved to ≤ grade 1
- At least 28 days since prior anticancer or investigational agent (within predicted 5 half-lives of agent)
- More than 4 weeks since prior radiotherapy to target lesions and documented disease progression at these sites
- More than 2 weeks since prior radiotherapy to non-target lesions
- More than 4 months since prior major surgery or hormonal therapy (other than replacement)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Colorado
Denver, Colorado, 80217-3364
About this study
Official title: A Phase I/Randomized Phase II Study of the Anti-IGF-1R Monoclonal Antibody IMC-A12 in Combination With Erlotinib Compared With Erlotinib Alone in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, 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. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine a tolerable dose of IMC-A12 (cixutumumab) in combination with erlotinib (erlotinib hydrochloride) in the target NSCLC population to be administered in the randomized phase II study section.
II. To determine the difference in PFS between the anti-IGF-1R monoclonal antibody IMC-A12 in combination with erlotinib compared to erlotinib alone in the target NSCLC population.
SECONDARY OBJECTIVES:
- To evaluate the safety, tolerability, and adverse event profile of IMC-A12 in combination with erlotinib in patients with advanced non-small cell lung cancer.
II. To describe preliminary evidence of clinical activity of the combination of IMC-A12 and erlotinib.
III. To determine the difference in overall response rate (ORR) between the two treatment arms.
IV. To determine the response duration in patients who achieve an objective response in either study arm.
- To describe the response rate, time to disease progression, and response duration in the population who cross over to the combination arm after disease progression with single agent erlotinib therapy.
TERTIARY OBJECTIVES:
- To explore the prognostic/predictive significance of the immunohistochemical, mutational, and cytogenetic profiles from archived tumor tissue of key elements of the EGFR, IGF-1R and other relevant signaling pathways in relationship to clinical benefit from treated individuals in both Part A and Part B sections of the study.
II. To explore the prognostic/predictive significance of serum circulating markers (ligands and binding proteins) and serum proteomic profiles pre-treatment and at progression in both Part A and Part B sections of the study.
III. To explore the impact of SNPs in germline and tumor derived DNA on toxicity and anti-cancer activity within both Part A and Part B sections of the study.
IV. To explore the impact of SNPs in germline DNA on erlotinib pharmacokinetics within both Part A and Part B sections of the study.
OUTLINE: This is a multicenter study that includes a single-arm safety evaluation phase I followed by a randomized phase II study.
Initially, patients are enrolled in the safety evaluation phase. If ≤ 2 of 10 patients experience a dose-limiting toxicity, then the study may proceed to the randomized phase. Safety evaluation phase I: Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, 15, and 22 and erlotinib hydrochloride orally (PO) once daily on days 1-28. Courses repeat every 28 days until disease progression or unacceptable toxicity.
Randomized phase II: Patients are stratified according to performance status, history of smoking (never vs ex vs current), stage of disease (IIIA vs IIIB without malignant effusion vs IIIB with malignant effusion vs IV), EGFR mutation (present vs absent vs not known), and disease histology (squamous vs non-squamous). Patients are randomized to 1 of 2 treatment arms.
ARM 1: Patients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II.
ARM II: Patients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. Patients receive treatment in both arms as in the safety evaluation portion. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Archived tissue and blood samples are collected periodically for pharmacokinetic analysis of erlotinib hydrochloride; pharmacogenomic analysis of EGRF, IGF1R, and CYP3A4/5 mutations; IHC and FISH analysis of IGF1R, EGFR, cMET, ras, Akt1, and EMT; proteomic analysis of serum ligand/binding proteins (i.e., IGF1, IGF2, IGFBPs, EGF, HRG, and TGF-α) using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF); mutational status analysis of EGFR and related pathway proteins; and RT-PCR analysis.
After completion of study therapy, patients are followed for 4 weeks.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- cixutumumab, erlotinib hydrochloride, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cixutumumabBiological
Also called anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12
Given IV
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Enzyme inhibitor therapy) | Experimental | Patients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II. Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis |
| Arm II (Enzyme inhibitor and monoclonal antibody therapy) | Experimental | Patients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. Receives: Biological: cixutumumab; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)
Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.
Measured: From time of first dose up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2012
- Study completionMay 2012
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 Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Camidge, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778167
- Sponsor's protocol ID
- NCI-2009-00286
- Other IDs
- NCI-2009-00286, CDR0000617094, UCHSC-08-0044, COMIRB 08-0044, 8148, P30CA046934, N01CM62209, R21CA135595
- Status last verified
- Mar 2013
- First submitted
- 22 Oct 2008
- Last updated
- 21 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Randomized Phase II Study of the Anti-IGF-1R Monoclonal Antibody IMC-A12 in Combination With Erlotinib Compared With Erlotinib Alone in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00778167
- Acronym / sponsor ID
- NCI-2009-00286
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Posted 23 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, 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. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine a tolerable dose of IMC-A12 (cixutumumab) in combination with erlotinib (erlotinib hydrochloride) in the target NSCLC population to be administered in the randomized phase II study section.
II. To determine the difference in PFS between the anti-IGF-1R monoclonal antibody IMC-A12 in combination with erlotinib compared to erlotinib alone in the target NSCLC population.
SECONDARY OBJECTIVES:
- To evaluate the safety, tolerability, and adverse event profile of IMC-A12 in combination with erlotinib in patients with advanced non-small cell lung cancer.
II. To describe preliminary evidence of clinical activity of the combination of IMC-A12 and erlotinib.
III. To determine the difference in overall response rate (ORR) between the two treatment arms.
IV. To determine the response duration in patients who achieve an objective response in either study arm.
- To describe the response rate, time to disease progression, and response duration in the population who cross over to the combination arm after disease progression with single agent erlotinib therapy.
TERTIARY OBJECTIVES:
- To explore the prognostic/predictive significance of the immunohistochemical, mutational, and cytogenetic profiles from archived tumor tissue of key elements of the EGFR, IGF-1R and other relevant signaling pathways in relationship to clinical benefit from treated individuals in both Part A and Part B sections of the study.
II. To explore the prognostic/predictive significance of serum circulating markers (ligands and binding proteins) and serum proteomic profiles pre-treatment and at progression in both Part A and Part B sections of the study.
III. To explore the impact of SNPs in germline and tumor derived DNA on toxicity and anti-cancer activity within both Part A and Part B sections of the study.
IV. To explore the impact of SNPs in germline DNA on erlotinib pharmacokinetics within both Part A and Part B sections of the study.
OUTLINE: This is a multicenter study that includes a single-arm safety evaluation phase I followed by a randomized phase II study.
Initially, patients are enrolled in the safety evaluation phase. If ≤ 2 of 10 patients experience a dose-limiting toxicity, then the study may proceed to the randomized phase. Safety evaluation phase I: Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, 15, and 22 and erlotinib hydrochloride orally (PO) once daily on days 1-28. Courses repeat every 28 days until disease progression or unacceptable toxicity.
Randomized phase II: Patients are stratified according to performance status, history of smoking (never vs ex vs current), stage of disease (IIIA vs IIIB without malignant effusion vs IIIB with malignant effusion vs IV), EGFR mutation (present vs absent vs not known), and disease histology (squamous vs non-squamous). Patients are randomized to 1 of 2 treatment arms.
ARM 1: Patients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II.
ARM II: Patients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. Patients receive treatment in both arms as in the safety evaluation portion. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Archived tissue and blood samples are collected periodically for pharmacokinetic analysis of erlotinib hydrochloride; pharmacogenomic analysis of EGRF, IGF1R, and CYP3A4/5 mutations; IHC and FISH analysis of IGF1R, EGFR, cMET, ras, Akt1, and EMT; proteomic analysis of serum ligand/binding proteins (i.e., IGF1, IGF2, IGFBPs, EGF, HRG, and TGF-α) using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF); mutational status analysis of EGFR and related pathway proteins; and RT-PCR analysis.
After completion of study therapy, patients are followed for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Enzyme inhibitor therapy) | Experimental | Drug: erlotinib hydrochloride, Other: laboratory biomarker analysisPatients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II. |
| Arm II (Enzyme inhibitor and monoclonal antibody therapy) | Experimental | Biological: cixutumumab, Drug: erlotinib hydrochloride, Other: laboratory biomarker analysisPatients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Measurable disease, defined as ≥ 1unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Must have failed ≥ 1 platinum-containing chemotherapy regimen
- CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cixutumumabAlso: anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12Given IV | Biological | Arm II (Enzyme inhibitor and monoclonal antibody therapy) |
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given PO | Drug | Arm I (Enzyme inhibitor therapy), Arm II (Enzyme inhibitor and monoclonal antibody therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (Enzyme inhibitor therapy), Arm II (Enzyme inhibitor and monoclonal antibody therapy) |
Primary outcome
Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)
Time frame: From time of first dose up to 28 days
Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- 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.
David Camidge principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cixutumumab, erlotinib hydrochloride and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIA Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 2 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?
The sponsor lists 35 inclusion and 0 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: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Apr 2013). 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?
Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One) (time frame: From time of first dose up to 28 days). 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 21 May 2014.