Study of EC145 in Patients With Advanced Ovarian and Endometrial Cancers
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| 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 | |
| Study Director: | Richard A Messmann, MD, MHS, MSc | Endocyte |
More Information
Additional Information:
Publications:
| Responsible Party: | Endocyte |
| ClinicalTrials.gov Identifier: | NCT00507741 History of Changes |
| Other Study ID Numbers: | EC-FV-02 |
| Study First Received: | July 24, 2007 |
| Last Updated: | April 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endocyte:
|
Cancer Ovarian Endometrial |
Phase II EC145 EC20 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Ovarian Neoplasms Adenoma 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 Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 16, 2013