Trials / Completed
CompletedNCT03955042
Pemetrexed for the Treatment of Chordoma
Pilot Study of Pemetrexed for the Treatment of Chordoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Saint John's Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-06
- Primary completion
- 2022-07-27
- Completion
- 2023-01-18
- First posted
- 2019-05-17
- Last updated
- 2023-03-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03955042. Inclusion in this directory is not an endorsement.