Study Stopped
science has moved forward and there is no intent to complete the study
S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib
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
4 other identifiers
interventional
1
1 country
167
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2014
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
May 1, 2019
CompletedFebruary 20, 2020
February 1, 2020
2.1 years
May 7, 2014
April 11, 2019
February 19, 2020
Conditions
Outcome Measures
Primary Outcomes (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.
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)
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
Up to 3 years
Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy
Up to 3 years
Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium
Up to 3 years
Patterns of Failure
Up to 3 years
Overall Survival
Up to 3 years
Study Arms (2)
Arm I (crizotinib, pemetrexed disodium)
EXPERIMENTALPatients receive crizotinib PO BID on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
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.
Interventions
Given PO
Given IV
Correlative studies
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SWOG Cancer Research Networklead
- National Cancer Institute (NCI)collaborator
Study Sites (167)
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, 80909, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Kootenai Cancer
Sandpoint, Idaho, 83864, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Reid Health
Richmond, Indiana, 47374, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215, United States
Jewish Hospital Medical Center Northeast
Louisville, Kentucky, 40245, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, 65613, United States
CoxHealth Cancer Center
Branson, Missouri, 65616, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital-Joplin
Joplin, Missouri, 64804, United States
Phelps County Regional Medical Center
Rolla, Missouri, 65401, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Heartland Hematology and Oncology
Kearney, Nebraska, 68845, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, 68506, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Faith Regional Medical Offices West
Norfolk, Nebraska, 68701, United States
Great Plains Regional Medical Center
North Platte, Nebraska, 69103, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Hemotology and Oncology Consultants PC
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Oncology Hematology West
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Oncology Hematology West PC
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Regional West Medical Center
Scottsbluff, Nebraska, 69361, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, 03102, United States
Norris Cotton Cancer Center-Nashua
Nashua, New Hampshire, 03063, United States
Orange Regional Medical Center
Middletown, New York, 10940, United States
Asheville Hematology-Oncology Associates
Asheville, North Carolina, 28803, United States
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, 28792, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Delaware Radiation Oncology
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
SWOG
Portland, Oregon, 97239, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Memorial Hospital
Chattanooga, Tennessee, 37404, United States
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, 37343, United States
Memorial GYN Plus
Ooltewah, Tennessee, 37363, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Harrison Medical Center
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
Big Horn Basin Cancer Center
Cody, Wyoming, 82414, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Results Point of Contact
- Title
- Melanoma Statistician
- Organization
- SWOG
Study Officials
- PRINCIPAL INVESTIGATOR
David Camidge
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 9, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
February 20, 2020
Results First Posted
May 1, 2019
Record last verified: 2020-02