Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00216216 |
Recruitment Status :
Terminated
(The results from the interim analysis were not favorable to continue this trial.)
First Posted : September 22, 2005
Last Update Posted : May 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small Cell Lung Cancer | Drug: Pemetrexed | Phase 2 |
OUTLINE: This is a multi-center study.
- Pemetrexed 500 mg/m2 i.v. q 3 wks
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:
- WBC > 3000/mm3
- ANC > 1500/mm3
- Platelet count > 100,000/mm3
- Hemoglobin > 8 g/dL
Hepatic:
- Bilirubin < 1.0 X upper limit of normal
- Aspartate aminotransferase (AST, SGOT) < 2.5 x upper limit of normal. AST may be < 5 x upper limit of normal for patients with liver metastasis
Renal:
- Creatinine clearance of > 45 ml/ min (by Cockcroft-Gault)
Cardiovascular:
- No unstable or uncompensated cardiovascular conditions
Pulmonary:
- No unstable or uncompensated respiratory conditions
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78) |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
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Drug: Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks |
- - To estimate the clinical benefit rate (CR, PR, SD) of pemetrexed in two patient populations with small cell lung cancer: chemosensitive and chemoresistant relapsed independently. [ Time Frame: 12 months ]
- To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site [including lung] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the RECIST criteria
- Chemoresistant or chemosensitive disease
- Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent
- Radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to < grade 1 or baseline prior to registration
- Negative pregnancy test
Exclusion Criteria:
- No clinically significant infections as judged by the treating investigator
- No symptomatic CNS metastasis
- No radiation to > 25% of the marrow containing spaces
- No previous treatment with pemetrexed
- No uncontrolled pleural effusions
- No current breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216216
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 | |
Elkhart Clinic | |
Elkhart, Indiana, United States, 46515 | |
Oncology Hematology Associates of SW Indiana | |
Evansville, Indiana, United States, 47714 | |
Fort Wayne Oncology & Hematology, Inc | |
Fort Wayne, Indiana, United States, 46815 | |
Center for Cancer Care at Goshen Health System | |
Goshen, Indiana, United States, 46527 | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
Community Regional Cancer Center | |
Indianapolis, Indiana, United States, 46256 | |
Arnett Cancer Care | |
Lafayette, Indiana, United States, 47904 | |
Medical Consultants, P.C. | |
Muncie, Indiana, United States, 47303 | |
Center for Cancer Care, Inc., P.C. | |
New Albany, Indiana, United States, 47150 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
Northern Indiana Oncology Associates | |
South Bend, Indiana, United States, 46617 | |
AP&S Clinic | |
Terre Haute, Indiana, United States, 47804 | |
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 |
Publications of Results:
Responsible Party: | Nasser Hanna, M.D., Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00216216 |
Other Study ID Numbers: |
HOG LUN04-78 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | May 2, 2011 |
Last Verified: | April 2011 |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |