- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03955042
Pemetrexed for the Treatment of Chordoma
Pilot Study of Pemetrexed for the Treatment of Chordoma
The purpose of this study is to test the safety and tolerability of pemetrexed administered to people with chordoma. Other purposes of this study are to:
- find out side effects (good and bad) of pemetrexed;
- learn more about how pemetrexed might affect the growth of cancer cells;
- evaluate tumor characteristics by collecting tumor tissue samples if available;
- look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
- Participant has the willingness to comply with all study procedures and availability for the duration of the study.
- Participant has a diagnosis of chordoma.
- Participant is male or female, 18 years of age or older.
- Participant has a Karnofsky Performance Status of 50% or greater.
Participant has adequate organ function:
- ANC at least 1.5 x 10^9/L or higher
- Platelets at least 100 x 10^9/L or higher
- Hemoglobin at least 8 g/dL or higher.
- Total bilirubin 1.5 x upper limit of normal (ULN) or lower.
- ALT and AST 3 x ULN or lower.
- Serum creatinine 1.5 x ULN or lower.
- Participant has 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.
- Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.
Exclusion Criteria:
- Participant is less than 28 days from any investigational agent.
- Participant has third space fluid which cannot be controlled by drainage.
Participant has a severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study intervention, including, but not limited to:
- Uncontrolled diabetes;
- Renal disease that requires dialysis;
- Pulmonary disorder requiring supplemental oxygen to keep saturation >95% and the situation is not expected to resolve within 2 weeks;
- Severe dyspnea at rest or requiring oxygen therapy;
- Interstitial lung disease;
- History of major surgical resection involving the stomach or small bowel;
- Preexisting Crohn's disease;
- Ulcerative colitis;
- Uncontrolled vasculitis and/or disease with known vasculitis;
- Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Participant has an active bacterial infection requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C).
Participant has a personal history or presence of any of the following cardiovascular conditions:
- Syncope of cardiovascular etiology;
- Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);
- Myocardial infraction within 6 months of investigational product administration;
- Unstable angina;
- Sudden cardiac arrest;
- Congestive heart failure (NYHA classification ≥ 3).
- Participant is a female of childbearing potential who is pregnant or nursing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pemetrexed
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Pemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle.
Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: one year
|
duration of time from start of treatment until objective tumor progression or withdrawal
|
one year
|
Radiographic response assessed by RECIST v1.1
Time Frame: one year
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rate of radiographic imaging alterations following treatment
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one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity assessed by CTCAE v 4.03 criteria
Time Frame: one year
|
proportion of patients experiencing adverse events
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JWCI-18-0704
- H3E-US-X091 (Other Identifier: Eli Lilly)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chordoma
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Jonsson Comprehensive Cancer CenterBristol-Myers SquibbCompletedChordoma | Metastatic Chordoma | Unresectable Chordoma | Locally Advanced ChordomaUnited States
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M.D. Anderson Cancer CenterRecruitingChordoma | Metastatic Chordoma | Unresectable ChordomaUnited States
-
Institut CurieActive, not recruitingSkull Base Chordoma | Vertebral ChordomaFrance
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Heidelberg UniversityActive, not recruiting
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Huashan HospitalBoehringer IngelheimNot yet recruiting
-
Xuanwu Hospital, BeijingRecruiting
-
Massachusetts General HospitalM.D. Anderson Cancer Center; National Cancer Institute (NCI)Active, not recruitingChordoma of Sacrum | Chordoma of Spine | Chordoma of Base of Skull | Chondrosarcoma of the Spine | Chondrosarcoma of the SacrumUnited States
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CNAO National Center of Oncological HadrontherapyDept. of Electronics, Informatics, Bioengineering, Politecnico di Milano,...Recruiting
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National Cancer Institute (NCI)RecruitingGenes | Sporadic ChordomaUnited States
-
Hospices Civils de LyonRecruitingMalignant Tumors as Chordoma, Adenoid Cystic Carcinoma and SarcomaFrance
Clinical Trials on Pemetrexed
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Boehringer IngelheimTerminatedCarcinoma, Non-Small-Cell LungJapan
-
Shanghai Shengdi Pharmaceutical Co., LtdNot yet recruitingNon-squamous Non-small Cell Lung CancerChina
-
Rongjie TaoNational Natural Science Foundation of ChinaUnknown
-
Northwestern UniversityNational Cancer Institute (NCI)UnknownLymphoma | Brain and Central Nervous System Tumors | Metastatic CancerUnited States
-
PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
-
Ain Shams UniversityUnknown
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GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom
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Eli Lilly and CompanyCompletedNon-Small Cell Lung Cancer Metastatic | Nonsquamous Non-Small Cell Neoplasm of Lung | Non-Small Cell Lung Cancer Stage IIIBUnited Kingdom, Sweden
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University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted