Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers

This study has been completed.
Sponsor:
Collaborator:
Endocyte
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00507741
First received: July 24, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

This is a Phase II clinical trial evaluating the benefit from therapy with EC145 in patients with advanced ovarian and endometrial cancers.


Condition Intervention Phase
Ovarian Cancer
Endometrial Cancer
Drug: EC145
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocol EC-FV-02: A Phase II Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor responses to EC145 therapy. [ Time Frame: Duration of EC145 therapy will vary according to individual patient response. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Part A (enrollment complete): Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) CT, patient may proceed into maintenance phase, comprised of 4-week cycles with CT every 8 weeks. Patients continue on study until they experience disease progression, unacceptable toxicity, or attain protocol-defined maximum benefit.

Part B (enrollment complete): 4-week cycles with CT every 8 weeks. Patients continue on cycle until they experience disease progression, unacceptable toxicity, or attain protocol-defined maximum benefit.

Drug: EC145

Part A (enrollment complete): Induction Phase: EC145 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance Phase: EC145 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, patients may receive EC145 via an ambulatory pump after the first week of therapy has been administered in the clinic setting.

Part B (enrollment completed): EC145 2.5 mg intravenous injection, Monday, Wednesday and Friday, weeks 1 and 3 of each 4 week cycle. At the investigator's discretion, patients may receive EC145 via an ambulatory pump after the first week of therapy has been administered in the clinic setting.


Detailed Description:

This is a Phase II clinical trial of EC145 administered to patients with advanced ovarian and endometrial cancers.

EC145 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 EC145 may have antitumor effect in women with advanced ovarian cancer and that it is generally well-tolerated. This evidence suggests that EC145 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 EC145. The primary objective of Part B of this study is to collect data on the safety and efficacy of EC145.

All patients will undergo imaging with the FR targeting investigational imaging agent EC20(FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial. Clinical evidence suggests that EC20 may be used to identify women with cancers that express the target receptor.

Information about the safety and tolerability of both EC145 and EC20 will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Part A (enrollment complete):

Inclusion Criteria:

  • Radiographic evidence of measurable disease (by RECIST criteria) and either:

    • Advanced epithelial ovarian cancer with serous or endometrioid histology, as confirmed by previous biopsy or,
    • EC20 positive ovarian cancer, primary peritoneal cancer or adenocarcinoma of the endometrium.
  • Prior treatment with platinum and/or taxane compounds.
  • 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 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.
  • Patients who have been administered another radiopharmaceutical that would interfere with the assessment of 99mTc-EC20.

Part B (currently recruiting):

Inclusion Criteria:

  • Radiographic evidence of measurable disease (by RECIST criteria)
  • EC20 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.
  • Patients who have had prior therapy with Vinorelbine or vinca-containing compounds.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507741

Locations
United States, California
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
University of California
Los Angeles, California, United States, 90095
Woman's Cancer Research Foundation
Newport Beach, California, United States, 92663
North Valley Hematology/Oncology Medical
Northridge, California, United States, 91325
Ventura County Hematology-Oncology
Oxnard, California, United States, 93030
Wilshire Oncology Medical Group
Pomona, California, United States, 91767
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Indiana
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Karmanos Cancer Center at Detroit Medical Center
Detroit, Michigan, United States, 48201
United States, North Carolina
Blumenthal Cancer Center Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Endocyte
Investigators
Study Director: Richard A Messmann, MD, MHS, MSc Endocyte
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00507741     History of Changes
Other Study ID Numbers: 8109-007, EC-FV-02
Study First Received: July 24, 2007
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Cancer
Ovarian
Endometrial
Phase II
EC145
EC20

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 17, 2014