Carcinoma, Non-Small-Cell LungPhase 2NCT00215930
The 'MADe IT' Clinical Trial: Molecular Analyses Directed Individualized Therapy for Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Vinorelbine, Docetaxel and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity or by physician's preference. In this protocol, the treatment regimen will be assigned based on the patients' tumor molecular profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Vinorelbine, Docetaxel and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Oct 2009
- 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
- histologically confirmed adenocarcinoma, large cell or squamous cell carcinoma NSCLC; as well as be willing to undergo a biopsy to enable customization of chemotherapy; unresectable/ metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
- male or female, aged > 18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- adequate bone marrow, hepatic and renal function assessed within 14 days as evidenced by the following:
- absolute neutrophil count > 1,500/mm3
- platelet count > 100,000/mm3
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- Hemoglobin > 8gm/dl
- no evidence of myelodysplastic syndrome or abnormal bone marrow reserve;
- creatinine < 1.5 x upper normal limit(UNL)
- total bilirubin must be within normal limits
- aspartate aminotransferase(AST)Serum glutamic oxaloacetic transaminase(SGOT) and/or alanine aminotranserase (ALT) serum glutamic pyruvic transaminase(SGPT) < 2×5 x UNL in the presence of a normal alkaline phosphatase;
- alkaline phosphatases < 4 x UNL in the presence of normal AST and ALT; patients with elevations of both alkaline phosphatase and liver enzymes (AST \& ALT) will be excluded.
- serum calcium < 1.1 x UNL;
- at least one unidimensionally measurable lesion;
- signed informed consent;
- Women of childbearing potential should have negative pregnancy test prior to enrollment to study.
- Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.
- previous surgery (more that 30 days before study entry) is allowed but metastatic disease must be demonstrated;
- previous radiotherapy is allowed if:
- end of radiotherapy 21 days or more prior to study entry;
- patient has fully recovered from all toxic effects;
- at least one of the measurable target lesions is outside the radiation field.
- The patient will be enrolled and re-biopsied at the H Lee Moffitt Cancer Center. However since the patients are being treated by FDA approved drugs and with regimens for which phase I, phase II or phase III data are available the patients may have their chemotherapy administered at the their primary (referring) oncologists office.
- Complete initial staging work-up within 4 weeks prior to first infusion of chemotherapy.
- Patient should have a normal Prothrombin Time (PT) and Activated Prothrombin Time with Thromboplastin and kaolin (APTT), to enable him to undergo a biopsy.
- Peripheral neuropathy < grade I (according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE Version 3.0)
- Patients with stable brain metastases will be allowed to enroll. Stable brain metastases being defined as no progression of brain metastases 28 days after conclusion of definitive treatment as documented by a CT Scan or MRI of the Brain
Who cannot join
- Pregnant or lactating women
- Prior systemic chemotherapy or immunotherapy for advanced NSCLC, patients may have received neoadjuvant or adjuvant therapy but more than 6 months prior to study entry;
- Prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 3 years;
- presence of uncontrolled brain or leptomeningeal metastases;
- current peripheral neuropathy and hearing deficit of neural origin, CTCAE v3.0 grade 2 except if due to trauma;
- other serious illness or medical condition, including but not limited to:
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- congestive heart disease; prior myocardial infarction within 6 months;
- history of significant neurologic or psychiatric disorders that would inhibit their understanding and giving of informed consent;
- infection requiring I.V. antibiotics and tuberculosis under treatment ongoing at study entry;
- untreated superior vena cava syndrome;
- active peptic ulcer; unstable diabetes mellitus or other contraindication to high dose corticosteroid therapy such as herpes, herpes zoster, cirrhosis;
- hypercalcemia requiring therapy at the time of study entry;
- preexisting clinically significant ascites and/or clinical significant pericardial effusion;
- patients whose lesion(s) are assessable only by radionuclide scan;
- patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded
- concurrent treatment with other investigational drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC)
The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity or by physician's preference. In this protocol, the treatment regimen will be assigned based on the patients' tumor molecular profile. A tumor molecular profile analysis will allow the physician to define a specific molecular portrait that shows the genetic basis of the tumor. This analysis results in a detailed report that will determine which chemotherapy will be assigned to the patient.
Read the detailed description
Evaluation at study entry will include blood tests, computerized tomography (CT) scans or other types of scans needed to measure other disease sites. A biopsy of one tumor is required for tumor analysis. If the patient's cancer has spread to other locations that may be easier to obtain tissue from and be less invasive, then the biopsy specimen may be collected from one of several possible locations that may exist within the patient's body. These possible sites include lung, bone, liver, adrenal glands, lymph nodes, nodules under the skin, or in cases of brain involvement requiring surgery, brain tissue. Sometimes fluids build up between the lining of the lung and the lung itself. If this happened to the patient and their doctor tells them the fluid should be drained, then this fluid may also be a source of cells we can use to analyze the patients cancer. In very rare cases, other sites might be identified.
Chemotherapy will consist of the assigned two drugs. Chemotherapy will be repeated every three or four weeks for at least two times. Patients will then have a CT scan to measure their tumor's response. Response can be reduction of tumor size, no change of tumor size, or increased tumor size. Doing CT Scans or other tests after every two cycles of chemotherapy will assess for response. If we see a favorable response we will continue chemotherapy for a maximum of two times after the best response we can see in the patient's tumor. If the patient's tumor grows larger, then we discontinue the study and the patient will discuss other treatment options with their doctor.
During treatment, a blood specimen will be obtained to check the patient's blood counts at the beginning and end of study, and prior to administration of every dose of chemotherapy. Approximately 3 teaspoonfuls (15 mls) of blood will be drawn each time.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Vinorelbine, Docetaxel, Gemcitabine, Carboplatin
- Keywords
- malignant pleural effusion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine
Ribonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
DocetaxelDrug
Also called Taxotere
RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days.
RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days.
RRM1 above 16.5 and ERCC1 above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
GemcitabineDrug
Also called Gemzar
Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days.
CarboplatinDrug
Also called Paraplatin
Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Double Agent Chemotherapy | Experimental | Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of ERCC1 and RRM1. Receives: Drug: Vinorelbine; Drug: Docetaxel; Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Disease Response After a Maximum of Six Cycles.
Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.
Measured: 24 Months
Secondary outcomes (2)
Overall Survival (OS)
Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.
Measured: 24 Months
Progression Free Survival (PFS)
PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionOct 2009
- Study completionOct 2009
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 Carcinoma, Non-Small-Cell LungStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Gerold Bepler, MD, PhD, Principal investigator, H. Lee Moffitt Cancer Center & Research Institute (now at Karmanos Cancer Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215930
- Sponsor's protocol ID
- MCC-13208
- Status last verified
- Mar 2011
- First submitted
- 15 Sep 2005
- Last updated
- 23 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 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00215930
- Acronym / sponsor ID
- MCC-13208
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- malignant pleural effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Aventis Pharmaceuticals
- Study start
- Feb 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 23 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity or by physician's preference. In this protocol, the treatment regimen will be assigned based on the patients' tumor molecular profile. A tumor molecular profile analysis will allow the physician to define a specific molecular portrait that shows the genetic basis of the tumor. This analysis results in a detailed report that will determine which chemotherapy will be assigned to the patient.
Detailed description
Evaluation at study entry will include blood tests, computerized tomography (CT) scans or other types of scans needed to measure other disease sites. A biopsy of one tumor is required for tumor analysis. If the patient's cancer has spread to other locations that may be easier to obtain tissue from and be less invasive, then the biopsy specimen may be collected from one of several possible locations that may exist within the patient's body. These possible sites include lung, bone, liver, adrenal glands, lymph nodes, nodules under the skin, or in cases of brain involvement requiring surgery, brain tissue. Sometimes fluids build up between the lining of the lung and the lung itself. If this happened to the patient and their doctor tells them the fluid should be drained, then this fluid may also be a source of cells we can use to analyze the patients cancer. In very rare cases, other sites might be identified.
Chemotherapy will consist of the assigned two drugs. Chemotherapy will be repeated every three or four weeks for at least two times. Patients will then have a CT scan to measure their tumor's response. Response can be reduction of tumor size, no change of tumor size, or increased tumor size. Doing CT Scans or other tests after every two cycles of chemotherapy will assess for response. If we see a favorable response we will continue chemotherapy for a maximum of two times after the best response we can see in the patient's tumor. If the patient's tumor grows larger, then we discontinue the study and the patient will discuss other treatment options with their doctor.
During treatment, a blood specimen will be obtained to check the patient's blood counts at the beginning and end of study, and prior to administration of every dose of chemotherapy. Approximately 3 teaspoonfuls (15 mls) of blood will be drawn each time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double Agent Chemotherapy | Experimental | Drug: Vinorelbine, Drug: Docetaxel, Drug: Gemcitabine, Drug: CarboplatinMolecular Analysis-Directed Chemotherapy Assignment based on gene expression of ERCC1 and RRM1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- histologically confirmed adenocarcinoma, large cell or squamous cell carcinoma NSCLC; as well as be willing to undergo a biopsy to enable customization of chemotherapy; unresectable/ metastatic (stage IV or IIIB malignant pleural effusion) NSCLC;
- male or female, aged > 18 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- adequate bone marrow, hepatic and renal function assessed within 14 days as evidenced by the following:
- at least one unidimensionally measurable lesion;
Key exclusion criteria (16 listed)
- Pregnant or lactating women
- Prior systemic chemotherapy or immunotherapy for advanced NSCLC, patients may have received neoadjuvant or adjuvant therapy but more than 6 months prior to study entry;
- Prior malignancies, except cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with non-evidence of disease for at least 3 years;
- presence of uncontrolled brain or leptomeningeal metastases;
- current peripheral neuropathy and hearing deficit of neural origin, CTCAE v3.0 grade 2 except if due to trauma;
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 |
|---|---|---|
| VinorelbineAlso: NavelbineRibonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. | Drug | Double Agent Chemotherapy |
| DocetaxelAlso: TaxotereRRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. RRM1 above 16.5 and ERCC1 above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. | Drug | Double Agent Chemotherapy |
| GemcitabineAlso: GemzarRibonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days. RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. | Drug | Double Agent Chemotherapy |
| CarboplatinAlso: ParaplatinRibonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days. RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. | Drug | Double Agent Chemotherapy |
Primary outcome
Best Disease Response After a Maximum of Six Cycles.
Time frame: 24 Months
Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.
2 secondary outcomes
Overall Survival (OS)
Time frame: 24 Months
Progression Free Survival (PFS)
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Gerold Bepler, MD, PhD principal investigator
H. Lee Moffitt Cancer Center & Research Institute (now at Karmanos Cancer Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine, Docetaxel and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 16 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 23 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 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 23 Feb 2011). 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?
Best Disease Response After a Maximum of Six Cycles. (time frame: 24 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 23 Mar 2017.