![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Hoosier Oncology Group Eli Lilly and Company Walther Cancer Institute |
---|---|
Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00216216 |
Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis. Unfortunately, available treatments result in few durable responses. Pemetrexed is a well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity of pemetrexed in this palliative setting
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: Pemetrexed |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78) |
Enrollment: | 43 |
Study Start Date: | January 2005 |
Study Completion Date: | October 2005 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
|
Drug: Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks
|
OUTLINE: This is a multi-center study.
All patients will also receive folic acid 350-1000 mcg. po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, Vitamin B12 1000 mcg. IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, and dexamethasone 4 mg po bid the day before, the day of, and the day following each treatment with pemetrexed
Chest x-ray will be performed prior to each cycle (if other disease assessment by imaging is not performed) in order to ensure patients are not rapidly progressing.
Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects.
Performance Status: ECOG 0, 1, or 2
Life Expectancy: Not specified
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Delaware | |
Helen F. Graham Cancer Center | |
Newark, Delaware, United States, 19713 | |
United States, Illinois | |
Medical & Surgical Specialists, LLC | |
Galesburg, Illinois, United States, 61401 | |
United States, Indiana | |
AP&S Clinic | |
Terre Haute, Indiana, United States, 47804 | |
Arnett Cancer Care | |
Lafayette, Indiana, United States, 47904 | |
Elkhart Clinic | |
Elkhart, Indiana, United States, 46515 | |
Center for Cancer Care, Inc., P.C. | |
New Albany, Indiana, United States, 47150 | |
Community Regional Cancer Center | |
Indianapolis, Indiana, United States, 46256 | |
Center for Cancer Care at Goshen Health System | |
Goshen, Indiana, United States, 46527 | |
Fort Wayne Oncology & Hematology, Inc | |
Fort Wayne, Indiana, United States, 46815 | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
Medical Consultants, P.C. | |
Muncie, Indiana, United States, 47303 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
Oncology Hematology Associates of SW Indiana | |
Evansville, Indiana, United States, 47714 | |
Northern Indiana Oncology Associates | |
South Bend, Indiana, United States, 46617 | |
United States, Missouri | |
Siteman Cancer Center | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 |
Study Chair: | Nasser Hanna, M.D. | Hoosier Oncology Group, LLC |
Responsible Party: | Hoosier Oncology Group ( Nasser Hanna, M.D. ) |
Study ID Numbers: | HOG LUN04-78 |
Study First Received: | September 12, 2005 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00216216 |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Folic Acid Pemetrexed Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue |
Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |