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

NCT00507741 | Completed Phase 2

• 2 other identifiers: 8109-007EC-FV-02
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

Cancer; Ovarian; Endometrial; Phase II; EC145; EC20

Outcome Measures

Primary Outcomes (1)

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

  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)

• Tumor responses to EC145 therapy.

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

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

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

Study Arms (1)

Ertafolide + Vintafolide

EXPERIMENTAL

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.

Drug: Vintafolide; Drug: Ertafolide

Interventions

Vintafolide DRUG

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.

Ertafolide + Vintafolide

Ertafolide DRUG

Ertafolide + Vintafolide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Endocyte: lead

Related Publications (2)

• 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.

  PMID: 17483358 BACKGROUND

• 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.

  PMID: 24667717 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Neoplasms

Interventions

EC145

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 26, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 7, 2015

Record last verified: 2014-12