Clinical trial · Interventional
Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)
Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers
NCT00507741CI-TRIAL-00016538completedPhase 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 advanced ovarian and endometrial cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ertafolide | Drug | — | UNRESOLVED |
| Vintafolide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ertafolide + 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 ertafolide labeled with 20 to 25 mCi of technetium-99m Part A: 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, comprised of 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. Part B: 4-week cycles with CT every 8 weeks. Participants continue until they experience disease progression, unacceptable toxicity, or attain protocol-defined clinical benefit.
- interventionNames
- Drug: Vintafolide
- Drug: Ertafolide
Primary outcomes (1)
- measure
- Part A: Percentage of patients deriving clinical benefit. Part B: To gather pilot data on efficacy and toxicity of EC145.
- timeFrame
- Clinical benefit is defined as the ability to receive 6 or more cycles (i.e., months) of therapy without progression of disease.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Part A: Inclusion Criteria: * Radiographic evidence of measurable disease (by Response Evaluation Criteria In Solid Tumors \[RECIST\]) and either: * Advanced epithelial ovarian cancer with serous or endometrioid histology, as confirmed by previous biopsy or, * ertafolide scan positive ovarian cancer, primary peritoneal cancer or adenocarcinoma of the endometrium. * Prior treatment with platinum and/or taxane compounds. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2. * At least 4 weeks from prior therapy and recovered from associated acute toxicities. * Adequate bone marrow reserve, renal, and hepatic 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). * Women who are pregnant or lactating. * Symptomatic central nervous system (CNS) metastasis. * Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site. * Requires palliative radiotherapy at time of study entry. * Unable to tolerate conditions for radionuclide imaging. * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. * Those who have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-ertafolide scan. Part B: Inclusion Criteria: * Radiographic evidence of measurable disease (by RECIST criteria) * ertafolide scan positive recurrent or persistent epithelial ovarian, primary fallopian tube, or peritoneal cancer. * Prior treatment with platinum compounds, but not more than 4 prior cytotoxic chemotheraputic regimens. * ECOG Performance status of 0-2. * At least 3 weeks from prior cytotoxic therapy and recovered from associated acute toxicities. * Adequate bone marrow reserve, renal, and hepatic 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). * Women who are pregnant or lactating. * Symptomatic CNS metastasis. * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. * Those who have had prior therapy with Vinorelbine or vinca-containing compounds.
References
Publications (2)
- 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
- DERIVEDMorris RT, Joyrich RN, Naumann RW, Shah NP, Maurer AH, Strauss HW, Uszler JM, Symanowski JT, Ellis PR, Harb WA. Phase II study of treatment of advanced ovarian cancer with folate-receptor-targeted therapeutic (vintafolide) and companion SPECT-based imaging agent (99mTc-etarfolatide). Ann Oncol. 2014 Apr;25(4):852-858. doi: 10.1093/annonc/mdu024. PMID 24667717