Recurrent Non-small Cell Lung CancerPhase 2NCT00499655
Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
A Phase 2 study testing erlotinib hydrochloride, celecoxib and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells. 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 IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- erlotinib hydrochloride, celecoxib and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Dec 2016
- 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
Who may be able to join
- Pathologically proven NSCLC, stage IIIB (defined as: with pleural effusion or recurrence after mediastinal radiation and chemotherapy) or IV
- Available tumor tissue for mutation screening
- Measurable stage IIIb or IV disease by RECIST guidelines
- ECOG performance status of 0 or 1
- Progressive disease despite >= 1 prior chemotherapy regimens as standard of care or subject's refusal or inability to receive standard chemotherapy
- Normal renal function (defined as serum creatinine =< 2mg/dl)
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- Normal liver function (defined as serum total bilirubin =< 1.5, and serum transaminases =< 2.5X the upper limits of normal [ULN]); if liver metastases are present, serum transaminases > 5X the ULN
- No evidence of coagulopathy (defined as PT and/or PTT =< 1.5X ULN or platelets >= 100,000)
- No evidence of leukopenia (defined as absolute neutrophil count >= 1,500 mm^3)
- Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment
Who cannot join
- Cytotoxic chemotherapy agents within 4 weeks of initiating treatment; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
- Evidence of NYHA class III or greater cardiac disease, history of myocardial infarction, cerebral vascular accident, symptomatic ventricular arrhythmia, or symptomatic conduction abnormality
- Non-cytoxic therapy within 2 weeks of initiating treatment ; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
- Prior radiotherapy to target lesions is not permitted unless completed more than 4 weeks prior to treatment within the study and that there has been documented progression at these sites (Radiotherapy to non-target lesions is permitted within 2 weeks of study entry provided all acute effects of the radiotherapy have resolved at least grade 1)
- Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol
- Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer or cervical cancer in situ
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- Hypersensitivity of erlotinib or celecoxib or to any of the excipients of these products
- Hypersensitivity to sulfonamides, aspirin or other NSAIDS
- Prior history of EGFR inhibitor for the treatment of cancer
- Previous history of gastrointestinal ulceration, bleeding or perforation
- Concurrent use of COX-2 inhibitors or other NSAIDS (For subjects on NSAIDS prior to study initiation, cessation of the drug for 72 hours prior to study entry is required)
- Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated)
- Subjects who require treatment with fluconazole or lithium
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- Renal insufficiency (defined as serum creatinine > 2 mg/dl)
- Liver insufficiency (defined as serum total bilirubin > 1.5, or serum transaminases > 2.5C the upper limits of normal [ULN]); if liver metastases are present, serum transaminases > 5X the ULN
- Coagulopathy (defined as PT and/or PTT > 1.5X ULN or platelets < 100,000)
- Leukopenia (defined as absolute neutrophil count < 1,500/mm^3)
- Pregnancy or inadequate contraception
- Lactating females
- Active CNS metastasis (stable, treated CNS metastasis acceptable)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
South Pasadena Cancer Center
South Pasadena, California, 91030
About this study
Official title: A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients
RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib vs. erlotinib + placebo for advanced NSCLC.
SECONDARY OBJECTIVES:
- Objective tumor response rate as defined by RECIST Criteria for subjects receiving erlotinib/celecoxib treatment arms.
II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of subjects.
III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate with clinical response.
- Measurement of change in urinary PGE-M and correlation with response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- erlotinib hydrochloride, celecoxib, placebo, laboratory biomarker analysis, immunohistochemistry staining method
- 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.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774, Tarceva
Given orally
celecoxibDrug
Also called Celebrex, SC-58635, YM 177
Given orally
placeboOther
Also called PLCB
Given orally
laboratory biomarker analysisOther
Correlative studies
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative studies
fluorescence in situ hybridizationGenetic
Also called fluorescence in situ hybridization (FISH)
Correlative studies
mutation analysisGenetic
Correlative studies
protein expression analysisGenetic
Correlative studies
gene expression analysisGenetic
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. Receives: Drug: erlotinib hydrochloride; Other: placebo; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: fluorescence in situ hybridization; Genetic: mutation analysis; Genetic: protein expression analysis; Genetic: gene expression analysis |
| Arm II | Experimental | Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28. Receives: Drug: erlotinib hydrochloride; Drug: celecoxib; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: fluorescence in situ hybridization; Genetic: mutation analysis; Genetic: protein expression analysis; Genetic: gene expression analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Measured: Until disease progression, up to 5 years.
Secondary outcomes (4)
Number of Participants With Overall Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 16 weeks post start of treatment
Progression-free Survival - Elevated PGEM
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Measured: Until disease progression, up to 5 years.
Progression-free Survival - EGRF
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Measured: Until disease progression, up to 5 years.
Progression-free Survival - Low PGEM
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Measured: Until disease progression, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2016
- Study completionDec 2016
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 City of Hope Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Karen Reckamp, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499655
- Sponsor's protocol ID
- 06254
- Other IDs
- NCI-2010-00353, CDR0000549751
- Status last verified
- Feb 2017
- First submitted
- 10 Jul 2007
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00499655
- Acronym / sponsor ID
- 06254
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Study start
- Nov 2007
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Posted 1 Mar 2017
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 and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib vs. erlotinib + placebo for advanced NSCLC.
SECONDARY OBJECTIVES:
- Objective tumor response rate as defined by RECIST Criteria for subjects receiving erlotinib/celecoxib treatment arms.
II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of subjects.
III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate with clinical response.
- Measurement of change in urinary PGE-M and correlation with response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.
ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: erlotinib hydrochloride, Other: placebo, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: fluorescence in situ hybridization, Genetic: mutation analysis, Genetic: protein expression analysis, Genetic: gene expression analysisPatients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. |
| Arm II | Experimental | Drug: erlotinib hydrochloride, Drug: celecoxib, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: fluorescence in situ hybridization, Genetic: mutation analysis, Genetic: protein expression analysis, Genetic: gene expression analysisPatients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically proven NSCLC, stage IIIB (defined as: with pleural effusion or recurrence after mediastinal radiation and chemotherapy) or IV
- Available tumor tissue for mutation screening
- Measurable stage IIIb or IV disease by RECIST guidelines
- ECOG performance status of 0 or 1
- Progressive disease despite >= 1 prior chemotherapy regimens as standard of care or subject's refusal or inability to receive standard chemotherapy
Key exclusion criteria (21 listed)
- Cytotoxic chemotherapy agents within 4 weeks of initiating treatment; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
- Evidence of NYHA class III or greater cardiac disease, history of myocardial infarction, cerebral vascular accident, symptomatic ventricular arrhythmia, or symptomatic conduction abnormality
- Non-cytoxic therapy within 2 weeks of initiating treatment ; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
- Prior radiotherapy to target lesions is not permitted unless completed more than 4 weeks prior to treatment within the study and that there has been documented progression at these sites (Radiotherapy to non-target lesions is permitted within 2 weeks of study entry provided all acute effects of the radiotherapy have resolved at least grade 1)
- Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol
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 |
|---|---|---|
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774, TarcevaGiven orally | Drug | Arm I, Arm II |
| celecoxibAlso: Celebrex, SC-58635, YM 177Given orally | Drug | Arm II |
| placeboAlso: PLCBGiven orally | Other | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I, Arm II |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative studies | Other | Arm I, Arm II |
| fluorescence in situ hybridizationAlso: fluorescence in situ hybridization (FISH)Correlative studies | Genetic | Arm I, Arm II |
| mutation analysisCorrelative studies | Genetic | Arm I, Arm II |
| protein expression analysisCorrelative studies | Genetic | Arm I, Arm II |
| gene expression analysisCorrelative studies | Genetic | Arm I, Arm II |
Primary outcome
Progression-free Survival
Time frame: Until disease progression, up to 5 years.
Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
4 secondary outcomes
Number of Participants With Overall Response
Time frame: 16 weeks post start of treatment
Progression-free Survival - Elevated PGEM
Time frame: Until disease progression, up to 5 years.
Progression-free Survival - EGRF
Time frame: Until disease progression, up to 5 years.
Progression-free Survival - Low PGEM
Time frame: Until disease progression, up to 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- 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.
Karen Reckamp principal investigator
City of Hope Medical Center
2 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 erlotinib hydrochloride, celecoxib and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by City of Hope Medical Center 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 10 inclusion and 21 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 29 Mar 2017. 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 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 1 Mar 2017). 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?
Progression-free Survival (time frame: Until disease progression, up to 5 years.). 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 29 Mar 2017.