Clinical trial · Interventional
Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)
Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung
NCT00511485CI-TRIAL-00016949completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with progressive adenocarcinoma of the lung.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etarfolatide | Drug | — | UNRESOLVED |
| Vintafolide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Etarfolatide + Vintafolide
- description
- Screening: After completion of all screening procedures and confirmation of eligibility, all participants receive a 1- to 2-mL injection of 0.1 mg etarfolatide labeled with 20 to 25 mCi of technetium-99m. Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) computed tomography (CT), participant may proceed into maintenance phase. Maintenance phase of treatment: 4-week cycles with CT every 8 weeks. Participants continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined clinical benefit.
- interventionNames
- Drug: Vintafolide
- Drug: Etarfolatide
Primary outcomes (1)
- measure
- Percentage of patients deriving clinical benefit
- timeFrame
- Clinical benefit is defined as the ability to receive 4 or more cycles (i.e., months) of therapy without progression of disease.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced, progressive, adenocarcinoma of the lung. * Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can include an epidermal growth factor receptor \[EGFR\] inhibitor). There is no upper limit to the number of prior chemotherapeutic regimens. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * At least 4 weeks from prior therapy and recovered from associated acute toxicities. * Radiographic evidence of measurable disease and ertafolide "positive" tumor. * Adequate bone marrow reserve, hepatic, and renal function. * Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods. Exclusion Criteria: * Serious comorbidities (as determined by the Principal Investigator). * History of carcinomatous peritonitis. * History of severe bowel obstruction (as determined by the Principal Investigator). * Women who are pregnant or lactating. * Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site. * Participants requiring palliative radiotherapy at time of study entry. Note: Participants with central nervous system (CNS) metastasis are eligible if a) they have been treated for the CNS metastasis and have been clinically stable (with regard to their CNS disease) for \>4 weeks and b) they do not require steroids or antiseizure medications (i.e., for seizure control), or if the CNS metastasis has been untreated to date, it is not associated with a midline shift or significant edema and there is no clinically-evident requirement for steroids or antiseizure medication. In either situation, participants must be off steroids and/or antiseizure medications for at least 14 days.
References
Publications (1)
- BACKGROUNDReddy JA, Dorton R, Westrick E, Dawson A, Smith T, Xu LC, Vetzel M, Kleindl P, Vlahov IR, Leamon CP. Preclinical evaluation of EC145, a folate-vinca alkaloid conjugate. Cancer Res. 2007 May 1;67(9):4434-42. doi: 10.1158/0008-5472.CAN-07-0033. PMID 17483358