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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Endometrial Cancer

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Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Clinical benefit is defined as the ability to receive 6 or more cycles (i.e., months) of therapy without progression of disease.

Safety Issue:

No

Principal Investigator

Richard A Messmann, MD, MHS, MSc

Investigator Role:

Study Director

Investigator Affiliation:

Endocyte

Authority:

United States: Food and Drug Administration

Study ID:

EC-FV-02

NCT ID:

NCT00507741

Start Date:

August 2007

Completion Date:

June 2011

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • Cancer
  • Ovarian
  • Endometrial
  • Phase II
  • EC145
  • EC20
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Ovarian Neoplasms
  • Adenoma

Name

Location

Comprehensive Blood and Cancer CenterBakersfield, California  93309
Methodist HospitalHouston, Texas  77030
Wilshire Oncology Medical GroupGlendora, California  91741
Cancer Care Associates Medical Group, Inc.Torrance, California  90505
St. Vincent Gynecologic OncologyIndianapolis, Indiana  46260
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
University of CaliforniaSan Francisco, California  94108
Central Hematology Oncology Medical Group, Inc.Alhambra, California  91801
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Horizon Oncology CenterLafayette, Indiana  47905
St. Jude Heritage HealthcareFullerton, California  92835
Woman's Cancer Research FoundationNewport Beach, California  92663
North Valley Hematology/Oncology MedicalNorthridge, California  91325
Ventura County Hematology-OncologyOxnard, California  93030
Karmanos Cancer Center at Detroit Medical CenterDetroit, Michigan  48201
Blumenthal Cancer Center Carolinas Medical CenterCharlotte, North Carolina  28203