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Ovarian CancerPhase 2NCT00507741

Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)

A Phase 2 study testing Vintafolide and Ertafolide in people with Ovarian Cancer and Endometrial Cancer, run by Endocyte.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with advanced ovarian and endometrial cancers. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Endometrial Cancer
What is being tested?
Vintafolide and Ertafolide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Aug 2007to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Adequate bone marrow reserve, renal, and hepatic function.
  • Negative serum pregnancy test for women of childbearing potential and willingness to practice contraceptive methods.
  • 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.

Who cannot join

  • 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.
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  • 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:
  • 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.

About this study

Official title: Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers

This is a Phase II clinical trial evaluating the benefit from therapy with vintafolide in participants with advanced ovarian and endometrial cancers.

Read the 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.

Being tested
Vintafolide, Ertafolide
Keywords
Cancer, Ovarian, Endometrial, Phase II, EC145, EC20
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VintafolideDrug

    Part A: Induction Phase: vintafolide 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance Phase: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting. Part B: vintafolide 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, participants may receive vintafolide via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

  • ErtafolideDrug

Study groups in NCT00507741
Study groupRoleWhat they receive
Ertafolide + VintafolideExperimentalScreening: 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.
Receives: Drug: Vintafolide; Drug: Ertafolide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percentage of patients deriving clinical benefit. Part B: To gather pilot data on efficacy and toxicity of EC145.

    Measured: 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)

  1. Tumor responses to EC145 therapy.

    Measured: Duration of EC145 therapy will vary according to individual patient response.

  2. Progression-free survival, response duration, and overall survival time observed after EC145 therapy.

    Measured: 2 years after completing therapy with EC145 and the 30-day follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00507741
Sponsor's protocol ID
8109-007
Other IDs
EC-FV-02
Status last verified
Dec 2014
First submitted
24 Jul 2007
Last updated
7 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Reddy 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.

    PubMed 17483358

  • Morris 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.

    PubMed 24667717

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vintafolide and Ertafolide in people with Ovarian Cancer and Endometrial Cancer, run by Endocyte.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Percentage of patients deriving clinical benefit. Part B: To gather pilot data on efficacy and toxicity of EC145. (time frame: Clinical benefit is defined as the ability to receive 6 or more cycles (i.e., months) of therapy without progression of disease.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00507741, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015.

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