Non-Small-Cell Lung CancerPhase 2NCT01042288
Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC
A Phase 2 study testing Carboplatin, Pemetrexed and Panitumumab in people with Non-Small-Cell Lung Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.
Trial summary
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Carboplatin, Pemetrexed and Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2010to Jul 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
Who may be able to join
- Age ≥18 years.
- Histologically confirmed non-squamous NSCLC (squamous cell histology is ineligible). Cytologic specimens obtained by brushings, washings or needle aspiration of the defined lesion are acceptable. Sputum cytology alone is not acceptable. Mixed tumors with small cell elements are not eligible.
- Newly diagnosed unresectable stage IIIB or stage IV disease. Patients with stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
- At least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable disease is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Demonstration of K-ras wild type in archived tumor tissue. Tissue must be available for testing or results from previous K-ras testing must be available at the time of registration.
- No prior antineoplastic chemotherapy for metastatic lung cancer. Patients may have received adjuvant treatment for stage I, II or III disease.
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- For patients who have had previous radiotherapy as definitive therapy for locally advanced NSCLC, recurrence must be outside of the original radiation therapy port. Radiation therapy must have been completed more than four weeks prior to study entry. Previous radiation must have covered < 30% of marrow bearing area.
- Full recovery from surgery for patients who have undergone thoracotomy. Patients cannot start protocol treatment until at least three weeks after an operative procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Normal bone marrow function within 7 days prior to initial treatment as defined by:
- absolute neutrophil count (ANC) ≥1500/µL
- platelets ≥100,000/µL
- hemoglobin ≥8.0 g/dL. Patients may receive transfusions or erythropoietin to maintain or exceed this level.
- Normal hepatic function as defined by:
- bilirubin ≤1.5 x institutional upper limit of normal (ULN).
- transaminases ≤2.5 x institutional ULN. In the presence of known hepatic metastases, transaminases may be ≤5 x institutional ULN.
- Normal renal function within 7 days prior to initial treatment as defined by:
- serum creatinine <2.0 mg/dL
- estimated creatinine clearance (CrCl) ≥ 45 mL/min calculated by the Cockcroft-Gault method.
- Normal metabolic function as follows:
- Magnesium ≥ institutional lower limit of normal (LLN)
- The ability to take folic acid, vitamin B12, and dexamethasone according to the protocol.
- The ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
- Negative serum or urine pregnancy test within 7 days prior to initial study treatment.
- Agreement of women of child-bearing potential (WOCBP) and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) to prevent contraception during treatment and for a minimum of 6 months after the last study treatment.
- Willingness and ability to comply with study and follow-up procedures.
- Ability to understand the nature of this study and give written informed consent.
Who cannot join
- NSCLC with squamous cell histology.
- History of any invasive cancer treated within the previous 5 years with the exception of the disease under study, curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- Prior therapy which specifically and directly targets the EGFR pathway (e.g., cetuximab, gefitinib, erlotinib, lapatinib).
- Active brain or meningeal metastases. Patients must have completed any previous radiotherapy at least four weeks prior to study entry and recovered from any toxicity associated with radiotherapy. Patients must have no on-going requirement for and must have discontinued corticosteroids.
- Pregnancy or breast-feeding.
- A serious active infection at the time of treatment or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
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- Acute hepatitis or known human immunodeficiency virus (HIV) infection.
- Presence of third space fluid which is clinically significant and cannot be controlled by drainage.
- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan).
- History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
- Prior severe infusion reaction to a monoclonal antibody or history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (e.g., carboplatin, pemetrexed).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33916
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505
Baptist Hospital East
Louisville, Kentucky, 40207
Norton Cancer Institute
Louisville, Kentucky, 40207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Peninsula Cancer Institute
Newport News, Virginia, 23601
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801
About this study
Official title: A Phase II Trial of Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type Non-Small-Cell Lung Cancer
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Carboplatin, Pemetrexed, Panitumumab
- Keywords
- Non-Small-Cell Lung Cancer, NSCLC, Panitumumab, Vectibix, Pemetrexed, Alimta, Carboplatin
- 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.
CarboplatinDrug
Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
PemetrexedDrug
Also called Alimta
Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
PanitumumabDrug
Also called Vectibix
Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin/Pemetrexed/Panitumumab | Experimental | Systemic Therapy Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Progression (TTP)
Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.
Measured: 18 months
Secondary outcomes (4)
Median Progression-free Survival (PFS)
Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.
Measured: Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months
Median Overall Survival (OS)
Defined as the time between Day 1-Cycle 1 to the date of death from any cause.
Measured: 18 months
Objective Response Rate
Measured: Projected 18 months
Frequency of Adverse Events and Severity as a Measure of Toxicity
Assessed using NCI CTCAE v4.0
Measured: Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2014
- Study completionJul 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 Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- David R Spigel, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042288
- Sponsor's protocol ID
- SCRI LUN 183
- Status last verified
- Apr 2016
- First submitted
- 31 Dec 2009
- Last updated
- 11 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01042288
- Acronym / sponsor ID
- SCRI LUN 183
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Non-Small-Cell Lung Cancer, NSCLC, Panitumumab, Vectibix, Pemetrexed, Alimta, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jun 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin/Pemetrexed/Panitumumab | Experimental | Drug: Carboplatin, Drug: Pemetrexed, Drug: PanitumumabSystemic Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age ≥18 years.
- Histologically confirmed non-squamous NSCLC (squamous cell histology is ineligible). Cytologic specimens obtained by brushings, washings or needle aspiration of the defined lesion are acceptable. Sputum cytology alone is not acceptable. Mixed tumors with small cell elements are not eligible.
- Newly diagnosed unresectable stage IIIB or stage IV disease. Patients with stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
- At least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable disease is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Demonstration of K-ras wild type in archived tumor tissue. Tissue must be available for testing or results from previous K-ras testing must be available at the time of registration.
Key exclusion criteria (11 listed)
- NSCLC with squamous cell histology.
- History of any invasive cancer treated within the previous 5 years with the exception of the disease under study, curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- Prior therapy which specifically and directly targets the EGFR pathway (e.g., cetuximab, gefitinib, erlotinib, lapatinib).
- Active brain or meningeal metastases. Patients must have completed any previous radiotherapy at least four weeks prior to study entry and recovered from any toxicity associated with radiotherapy. Patients must have no on-going requirement for and must have discontinued corticosteroids.
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| CarboplatinCarboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) | Drug | Carboplatin/Pemetrexed/Panitumumab |
| PemetrexedAlso: AlimtaPemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) | Drug | Carboplatin/Pemetrexed/Panitumumab |
| PanitumumabAlso: VectibixPanitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length) | Drug | Carboplatin/Pemetrexed/Panitumumab |
Primary outcome
Median Time to Progression (TTP)
Time frame: 18 months
Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.
4 secondary outcomes
Median Progression-free Survival (PFS)
Time frame: Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months
Median Overall Survival (OS)
Time frame: 18 months
Objective Response Rate
Time frame: Projected 18 months
Frequency of Adverse Events and Severity as a Measure of Toxicity
Time frame: Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- 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 R Spigel, MD study chair
SCRI Development Innovations, LLC
13 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 Carboplatin, Pemetrexed and Panitumumab in people with Non-Small-Cell Lung Cancer, run by SCRI Development Innovations, LLC at 13 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 28 inclusion and 11 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 15 Apr 2016). 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?
Median Time to Progression (TTP) (time frame: 18 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 11 May 2016.