Brief Title
Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)
Official Title
Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers
Brief Summary
This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in
participants with advanced ovarian and endometrial cancers.
Detailed Description
This is a Phase II clinical trial of vintafolide administered to participants with advanced
ovarian and endometrial cancers.
Vintafolide is a drug that is specifically designed to enter cancer cells via the folate
vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on
virtually all ovarian cancers as well as the majority of endometrial cancers. Early clinical
evidence in a small number of Phase I patients suggests that vintafolide may have antitumor
effect in women with advanced ovarian cancer and that it is generally well-tolerated. This
evidence suggests that vintafolide may be useful as chemotherapy against advanced ovarian and
endometrial cancers. The primary objective of Part A of this study is to collect data on
clinical benefit produced by therapy with vintafolide. The primary objective of Part B of
this study is to collect data on the safety and efficacy of vintafolide.
All participants will undergo imaging with the FR targeting investigational imaging agent
ertafolide (EC20, FolateScan) during the screening period to confirm eligibility for the
treatment portion of the clinical trial. Clinical evidence suggests that ertafolide may be
used to identify women with cancers that express the target receptor.
Information about the safety and tolerability of both vintafolide and ertafolide will be
assessed.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Part A: Percentage of patients deriving clinical benefit. Part B: To gather pilot data on efficacy and toxicity of EC145.
Secondary Outcome
Tumor responses to EC145 therapy.
Condition
Ovarian Cancer
Intervention
Vintafolide
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
49
Start Date
August 2007
Completion Date
April 2009
Primary Completion Date
April 2009
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Director, ,
Administrative Informations
NCT ID
NCT00507741
Organization ID
8109-007
Secondary IDs
EC-FV-02
Responsible Party
Sponsor
Study Sponsor
Endocyte
Study Sponsor
Medical Director, Study Director, Merck Sharp & Dohme LLC
Verification Date
December 2014