Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung
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Purpose
This is a Phase II clinical trial evaluating the benefit from therapy with EC145 in patients with progressive adenocarcinoma of the lung.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Lung |
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-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung |
- Percentage of patients deriving clinical benefit. [ Time Frame: Clinical benefit is defined as the ability to receive 4 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: | 41 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Induction phase of treatment: Two 4-week cycles; if stable disease or better at (week 8) CT, patient may proceed into maintenance phase. Maintenance phase of treatment: 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. |
Drug: EC145
Induction: EC145 1.0 mg intravenous injection, Monday through Friday, for the first 3 weeks of each 4 week cycle. Maintenance: 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 progressive adenocarcinoma of the lung.
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 a significant portion of non-small cell lung cancers. Early clinical evidence in a small number of Phase I patients suggests that EC145 is generally well-tolerated, without many of the side-effects observed in more-standard therapeutic agents. This evidence suggests that EC145 may be useful as a chemotherapy against progressive adenocarcinomas of the lung. The primary objective of this study is to collect data on clinical benefit produced by therapy with 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 patients 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: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Advanced, progressive, adenocarcinoma of the lung.
- Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can include an EGFR inhibitor). There is no upper limit to the number of prior chemotherapeutic regimens.
- ECOG performance status of 0-2.
- At least 4 weeks from prior therapy and recovered from associated acute toxicities.
- Radiographic evidence of measurable disease and EC20 "positive" tumor.
- Adequate bone marrow reserve, hepatic, and renal 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).
- History of carcinomatous peritonitis.
- History of severe bowel obstruction (as determined by the Principal Investigator).
- Women who are pregnant or lactating.
- Prior radiation therapy to assessable disease, unless disease progression is confirmed at that site.
- Patients requiring palliative radiotherapy at time of study entry.
Note: Patients with CNS metastasis are eligible if a) they have been treated for the CNS metastasis and have been clinically stable (with regard to their CNS disease) for >4 weeks and b) they do not require steroids or antiseizure medications (i.e., for seizure control), or if the CNS metastasis has been untreated to date, it is not associated with a midline shift or significant edema and there is no clinically-evident requirement for steroids or antiseizure medication. In either situation, patients must be off steroids and/or antiseizure medications for at least 14 days.
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 | |
| UCLA Division of Hematology-Oncology | |
| Los Angeles, California, United States, 90095 | |
| North Valley Hematology/Oncology Medical Group | |
| Northridge, California, United States, 91325 | |
| Ventura County Hematology-Oncology | |
| Oxnard, California, United States, 93030 | |
| 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, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Division of Hematology/Oncology Research | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Horizon Oncology Center | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201 | |
| Center for Blood and Cancer Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Michigan | |
| Great Lakes Cancer Institute MSU | |
| Lansing, Michigan, United States, 48910 | |
| Providence Cancer Institute | |
| Southfield, Michigan, United States, 48075 | |
| United States, Missouri | |
| Washington University Medical School | |
| St. Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| Blumenthal Cancer Center | |
| Charlotte, North Carolina, United States, 28277 | |
| United States, Pennsylvania | |
| Donald Guthrie Foundation for Education and Research Clinical Research | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, Texas | |
| Methodist Hospital | |
| Houston, Texas, United States, 77031 | |
| United States, West Virginia | |
| West Virginia University Mary Babb Randolph Cancer Center | |
| Morgantown, West Virginia, United States, 26506 | |
| Study Director: | Richard A Messmann, MD, MHS, MSc | Endocyte |
| Principal Investigator: | Martin J Edelman, MD | University of Maryland Greenebaum Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Endocyte |
| ClinicalTrials.gov Identifier: | NCT00511485 History of Changes |
| Other Study ID Numbers: | EC-FV-03 |
| Study First Received: | August 2, 2007 |
| Last Updated: | March 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Endocyte:
|
Cancer Adenocarcinoma Phase II Lung |
Non-small cell lung cancer NSCLC EC145 EC20 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013