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Pemetrexed for the Treatment of Chordoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03955042
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : October 2, 2019
Eli Lilly and Company
Chordoma Foundation
Information provided by (Responsible Party):
Santosh Kesari, John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE September 6, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Progression free survival [ Time Frame: one year ]
    duration of time from start of treatment until objective tumor progression or withdrawal
  • Radiographic response assessed by RECIST v1.1 [ Time Frame: one year ]
    rate of radiographic imaging alterations following treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Toxicity assessed by CTCAE v 4.03 criteria [ Time Frame: one year ]
proportion of patients experiencing adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pemetrexed for the Treatment of Chordoma
Official Title  ICMJE Pilot Study of Pemetrexed for the Treatment of Chordoma
Brief Summary

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.
Detailed Description This is a prospective, open-label, single-arm pilot feasibility study of pemetrexed for the treatment of adult patients with chordoma. All patients providing informed consent will be screened for eligibility. Eligible patients will receive pemetrexed by intravenous infusion on Day 1 of each 21-day treatment cycle, pre-medications (folic acid, vitamin B12, and dexamethasone), and ibuprofen if needed. Patients will continue dosing of pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or treating physician determines it is in their best interest to stop. All patients will have regular evaluations for assessment of safety parameters and anti-tumor activity as detailed in the study flow chart.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chordoma
Intervention  ICMJE Drug: Pemetrexed
Pemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
Other Name: Alimta
Study Arms  ICMJE Experimental: Pemetrexed
Intervention: Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
  2. Participant has the willingness to comply with all study procedures and availability for the duration of the study.
  3. Participant has a diagnosis of chordoma.
  4. Participant is male or female, 18 years of age or older.
  5. Participant has a Karnofsky Performance Status of 50% or greater.
  6. Participant has adequate organ function:

    1. ANC at least 1.5 x 10^9/L or higher
    2. Platelets at least 100 x 10^9/L or higher
    3. Hemoglobin at least 8 g/dL or higher.
    4. Total bilirubin 1.5 x upper limit of normal (ULN) or lower.
    5. ALT and AST 3 x ULN or lower.
    6. Serum creatinine 1.5 x ULN or lower.
  7. 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.
  8. Participant has the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  9. Participant has recovered from any previous therapy-related toxicity to CTCAE Grade 1 or to their clinical baseline at study entry.

Exclusion Criteria:

  1. Participant is less than 28 days from any investigational agent.
  2. Participant has third space fluid which cannot be controlled by drainage.
  3. 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:

    1. Uncontrolled diabetes;
    2. Renal disease that requires dialysis;
    3. Pulmonary disorder requiring supplemental oxygen to keep saturation >95% and the situation is not expected to resolve within 2 weeks;
    4. Severe dyspnea at rest or requiring oxygen therapy;
    5. Interstitial lung disease;
    6. History of major surgical resection involving the stomach or small bowel;
    7. Preexisting Crohn's disease;
    8. Ulcerative colitis;
    9. Uncontrolled vasculitis and/or disease with known vasculitis;
    10. Preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea;
    11. Psychiatric illness/social situations that would limit compliance with study requirements.
  4. 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).
  5. Participant has a personal history or presence of any of the following cardiovascular conditions:

    1. Syncope of cardiovascular etiology;
    2. Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation);
    3. Myocardial infraction within 6 months of investigational product administration;
    4. Unstable angina;
    5. Sudden cardiac arrest;
    6. Congestive heart failure (NYHA classification ≥ 3).
  6. Participant is a female of childbearing potential who is pregnant or nursing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Team 310-829-8265
Contact: Mini Gill, RN 310-582-7437
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03955042
Other Study ID Numbers  ICMJE JWCI-18-0704
H3E-US-X091 ( Other Identifier: Eli Lilly )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santosh Kesari, John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE
  • Eli Lilly and Company
  • Chordoma Foundation
Investigators  ICMJE
Principal Investigator: Santosh Kesari, MD, PhD John Wayne Cancer Institute
PRS Account John Wayne Cancer Institute
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP