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Pemetrexed for the Treatment of Chordoma

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ClinicalTrials.gov Identifier: NCT03955042
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Santosh Kesari, John Wayne Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Chordoma Drug: Pemetrexed Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Pemetrexed for the Treatment of Chordoma
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemetrexed
Pemetrexed
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




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: one year ]
    duration of time from start of treatment until objective tumor progression or withdrawal

  2. Radiographic response assessed by RECIST v1.1 [ Time Frame: one year ]
    rate of radiographic imaging alterations following treatment


Secondary Outcome Measures :
  1. Toxicity assessed by CTCAE v 4.03 criteria [ Time Frame: one year ]
    proportion of patients experiencing adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955042


Contacts
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Contact: Trial Team 310-829-8265 neuro.oncology@providence.org
Contact: Mini Gill, RN 310-582-7437 jaya.gill@providence.org

Sponsors and Collaborators
John Wayne Cancer Institute
Eli Lilly and Company
Investigators
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Principal Investigator: Santosh Kesari, MD, PhD John Wayne Cancer Institute

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Responsible Party: Santosh Kesari, Director, Neuro-Oncology, John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT03955042     History of Changes
Other Study ID Numbers: JWCI-18-0704
H3E-US-X091 ( Other Identifier: Eli Lilly )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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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

Additional relevant MeSH terms:
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Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors