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

Primary Purpose

Ovarian Cancer, Endometrial Cancer

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Vintafolide

Ertafolide

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer, Ovarian, Endometrial, Phase II, EC145, EC20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ertafolide + Vintafolide

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tumor responses to EC145 therapy.

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

Full Information

NCT ID

NCT00507741

First Posted

July 24, 2007

Last Updated

December 18, 2014

Sponsor

Endocyte

1. Study Identification

Unique Protocol Identification Number

NCT00507741

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endocyte

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Endometrial Cancer

Keywords

Cancer, Ovarian, Endometrial, Phase II, EC145, EC20

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ertafolide + Vintafolide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vintafolide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Ertafolide

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Tumor responses to EC145 therapy.

Time Frame

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

Title

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

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

17483358

Citation

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.

Results Reference

background

PubMed Identifier

24667717

Citation

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.

Results Reference

derived

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

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