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AzTrials

Adenocarcinoma of the LungPhase 2NCT02134912

S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib

A Phase 2 study testing crizotinib, pemetrexed disodium and laboratory biomarker analysis in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by SWOG Cancer Research Network at 167 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial studies how well pemetrexed disodium with or without crizotinib works in treating patients with stage IV non-small cell lung cancer that has progressed after crizotinib. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
crizotinib, pemetrexed disodium and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
167 sitesUnited States
Study dates
Aug 2014to Sep 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

  • Patients must have histologically or cytologically proven primary non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma, adenocarcinoma in situ, mixed histology with < 50% squamous or unspecified); patients with tumors having squamous cell components >= 50% are not eligible; disease must be stage IV
  • Patients must have documented ALK positivity at the time of initial crizotinib monotherapy using the Vysis Break-Apart FISH assay (or other Food and Drug Administration [FDA]-approved diagnostic test); samples are deemed to be FISH-positive if greater than or equal to 15% of scored tumor cells had split ALK 5' and 3' probe signals or had isolated 3' signal; FISH status must be documented on the Onstudy Form and a copy of the pathology report from the Vysis Break-Apart FISH assay (or other FDA-approved diagnostic test) must be submitted
  • Prior to registration, patients must have achieved clinical benefit with crizotinib monotherapy and subsequently have systemically progressed; clinical benefit is defined as having stable disease on crizotinib monotherapy for at least 90 days or achieving a confirmed partial or complete response; systemic progression is defined as progressive disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, excluding progression based on brain/CNS metastases alone
  • Patients must have received crizotinib monotherapy at 250 mg BID on a continuous dosing schedule for at least 90 days; patients must be planning to start treatment at least three days, but no more than 30 days after discontinuing crizotinib monotherapy; patients who were not able to tolerate 250 mg BID of crizotinib are not eligible for this study
  • Patients must be pemetrexed-naïve; patients may have received any number of prior chemotherapy or molecularly targeted agents; if crizotinib was used in the 1st line setting then chemotherapy naive patients are also eligible; if patient received crizotinib in combination with chemotherapy, prior chemotherapy must have been discontinued at least 14 days prior to registration and all adverse events must have resolved to =< grade 1
  • Patients must have measurable disease per RECIST documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form RECIST 1.1
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  • Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least 14 days following treatment or was not treated, but is asymptomatic, AND (2) patient has no residual neurological dysfunction off corticosteroids or anti-convulsants for at least 14 days
  • Patients may have received palliative radiotherapy to non-target lesions within 14 days prior to registration provided all radiotherapy related toxicities have resolved to =< grade 1 prior to registration; patients must not have received any major surgery within 28 days prior to registration
  • Patients must not have had any prior exposure to heat shock protein (HSP)90 inhibitors (such as IPI-504 or ganetespib) or non-crizotinib ALK inhibitors (such as AP26113 or LDK378)
  • Patients must be offered participation in the translational medicine studies; additionally if patient has biopsy accessible disease they must be offered participation in the translational medicine studies
  • Absolute neutrophil count (ANC) >= 1,500/ul
  • Platelet count >= 100,000/ul
  • Hemoglobin >= 9 g/dL
  • Serum bilirubin =< 2 X institutional upper limit of normal (IULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN
  • Estimated (calculated) or measured glomerular filtration rate >= 45 mL/min (or 45 mL/min/1.73 m^2); creatinine (mg/dl) used in calculation (Cockroft-Gault) must be obtained within 28 days prior to registration
  • Male patients must have free and total testosterone level obtained within 28 days prior to registration
  • Pre-study history and physical must be obtained with 28 days prior to registration
  • Patients must have Zubrod performance status 0-2 within 28 days prior to registration
  • Patients must be able to swallow capsules
  • Patients must have corrected QT (QTC) interval =< 480 msec on electrocardiogram (EKG) at baseline; patient with congenital long QT syndrome are not eligible
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • REGULATORY CRITERIA: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • REGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • CROSSOVER (STEP 2) REGISTRATION: Patients must have progressed systemically on Arm 2 of this study (pemetrexed monotherapy)
  • CROSSOVER (STEP 2) REGISTRATION: Patients must be registered to crossover (Step 2) within 30 days of discontinuing treatment on Arm 2 of this study
  • CROSSOVER (STEP 2) REGISTRATION: ANC >= 1,500/ul
  • CROSSOVER (STEP 2) REGISTRATION: Platelet count >= 100,000/ul
  • CROSSOVER (STEP 2) REGISTRATION: Serum bilirubin =< 2 X IULN
  • CROSSOVER (STEP 2) REGISTRATION: SGOT (AST) or SGPT (ALT) =< 2.5 x IULN
  • CROSSOVER (STEP 2) REGISTRATION: estimated (calculated) or measured glomerular filtration rate >= 45 mL/min (or 45 mL/min/1.73 m^2) within 28 days prior to registration; creatinine (mg/dl) used in calculation (Cockroft-Gault) must be obtained within 28 days prior to registration
  • CROSSOVER (STEP 2) REGISTRATION: male patients must have free and total testosterone level obtained within 28 days prior to Crossover (Step 2) Registration
  • CROSSOVER (STEP 2) REGISTRATION: patients must have Zubrod performance status 0-2 within 28 days prior to Crossover (Step 2) Registration

Who cannot join

None listed.

Trial locations and contacts

167 sites in 1 country.

167 sites in 1 country

United States167 sites

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Asheville Hematology-Oncology Associates

    Asheville, North Carolina, 28803

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • CoxHealth Cancer Center

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc - Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Colorado Springs

    Colorado Springs, Colorado, 80909

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Oncology Hematology Care Inc-Healthplex

    Fairfield, Ohio, 45014

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Park Ridge Hospital Breast Health Center

    Hendersonville, North Carolina, 28792

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital-Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Nebraska Hematology and Oncology

    Lincoln, Nebraska, 68506

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • Jewish Hospital Medical Center Northeast

    Louisville, Kentucky, 40245

  • Norris Cotton Cancer Center-Manchester

    Manchester, New Hampshire, 03102

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Norris Cotton Cancer Center-Nashua

    Nashua, New Hampshire, 03063

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Faith Regional Medical Offices West

    Norfolk, Nebraska, 68701

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Hemotology and Oncology Consultants PC

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Oncology Hematology West

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Oncology Hematology West PC

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Memorial GYN Plus

    Ooltewah, Tennessee, 37363

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • SWOG

    Portland, Oregon, 97239

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Reid Health

    Richmond, Indiana, 47374

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Saint John's Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Kootenai Cancer

    Sandpoint, Idaho, 83864

  • Regional West Medical Center

    Scottsbluff, Nebraska, 69361

  • Jewish Hospital Medical Center South

    Shepherdsville, Kentucky, 40165

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Franciscan Research Center-Northwest Medical Plaza

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wright-Patterson Medical Center

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: S1300: A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-squamous NSCLC Patients Who Have Progressed Systemically After Previous Clinical Benefit From Crizotinib Monotherapy

This randomized phase II trial studies how well pemetrexed disodium with or without crizotinib works in treating patients with stage IV non-small cell lung cancer that has progressed after crizotinib. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving pemetrexed disodium is more effective with or without crizotinib in treating patients with non-small cell lung cancer that has progressed after crizotinib.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of the combination of crizotinib and pemetrexed (pemetrexed disodium) compared to pemetrexed monotherapy as measured by progression-free survival (PFS) in anaplastic lymphoma kinase (ALK)+ non-squamous non-small cell lung cancer (NSCLC) patients who achieved clinical benefit with crizotinib monotherapy and subsequently progressed systemically.

SECONDARY OBJECTIVES:

  1. To compare the response rate (confirmed and unconfirmed, complete and partial responses) in patients randomized to receive pemetrexed monotherapy to historical data.

II. To assess overall survival in both arms. III. To evaluate the patterns of failure (central nervous system [CNS], extra-CNS) of the combination of crizotinib and pemetrexed and of pemetrexed monotherapy in ALK+ non-squamous NSCLC after progression on crizotinib.

IV. To evaluate the frequency and severity of toxicities resulting from the administration of crizotinib and pemetrexed compared to pemetrexed monotherapy.

  1. To evaluate PFS and the response rate in patients treated with crizotinib following progression on the pemetrexed monotherapy arm.

TERTIARY OBJECTIVES:

  1. To compare progression-free survival (PFS) and response rates (RR) between ALK dominant and ALK non-dominant patients in the entire study population and within each treatment arm.

II. To evaluate if the magnitude of difference in these outcomes between ALK dominant and ALK non-dominant patients varies by treatment arm.

III. To assess blood biomarkers of sensitivity and resistance to crizotinib and pemetrexed in an exploratory manner. The blood biomarkers include cell free circulating deoxyribonucleic acid (DNA), micro ribonucleic acid (microRNA) before treatment, during treatment (after 2 cycles) and at treatment progression.

IV. To assess pharmacogenomic factors in peripheral blood that might affect the drug level and treatment outcomes in an exploratory manner.

  1. To assess proteomic/immunologic parameters that might affect the treatment outcomes in an exploratory manner.

VI. To evaluate the frequency of individual mechanisms of resistance (copy number gain [CNG], mutation, alternate oncogene).

VII. To identify alternative driver mechanisms in ALK fluorescence in situ hybridization positive (FISH+) otherwise unknown.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21 and pemetrexed disodium intravenously (IV) over 10 minutes on day 1.

ARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 years.

Being tested
crizotinib, pemetrexed disodium, laboratory biomarker analysis, pharmacological study
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • crizotinibDrug

    Also called c-met/hepatocyte growth factor receptor tyrosine kinase inhibitor PF-02341066, c-met/HGFR tyrosine kinase inhibitor PF-02341066, MET Tyrosine Kinase Inhibitor PF-02341066, PF-02341066

    Given PO

  • pemetrexed disodiumDrug

    Also called ALIMTA, LY231514, MTA

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT02134912
Study groupRoleWhat they receive
Arm I (crizotinib, pemetrexed disodium)ExperimentalPatients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
Receives: Drug: crizotinib; Drug: pemetrexed disodium; Other: laboratory biomarker analysis; Other: pharmacological study
Arm II (pemetrexed disodium)ExperimentalARM II: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Upon disease progression or symptomatic deterioration, patients may crossover to Arm I.
Receives: Drug: pemetrexed disodium; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy

    A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms.

    Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Secondary outcomes (5)

  1. Incidence of Adverse Events of Crizotinib in Combination With Pemetrexed Disodium, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    Comparisons of toxicities rates will be done using a Fisher's exact or chi-squared test of independence, when appropriate using 10% as the significance threshold. Within each treatment arm, any toxicity with at least 5% prevalence has at least a 95% chance of being observed.

    Measured: Up to 3 years

  2. Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy

    Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).

    Measured: Up to 3 years

  3. Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium

    Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).

    Measured: Up to 3 years

  4. Patterns of Failure

    Defined as CNS-only, extra-CNS, and both CNS and extra-CNS progression between the treatment arms. Evaluated within each treatment arm using cumulative incidence curves.

    Measured: Up to 3 years

  5. Overall Survival

    Differences in OS by treatment arm will be evaluated using a 1-sided log-rank test with significant level of 10%.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

Why it stopped: science has moved forward and there is no intent to complete the study

Resources

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
Crossover
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02134912
Sponsor's protocol ID
S1300
Other IDs
NCI-2014-00685, S1300, S1300, U10CA180888, U10CA032102
Status last verified
Feb 2020
First submitted
7 May 2014
Last updated
20 Feb 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing crizotinib, pemetrexed disodium and laboratory biomarker analysis in people with Adenocarcinoma of the Lung and Large Cell Lung Cancer, run by SWOG Cancer Research Network at 167 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 34 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: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 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 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy (time frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02134912.

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 20 Feb 2020.

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