Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
NCT ID: NCT00216216
Last Updated: 2011-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
43 participants
INTERVENTIONAL
2005-01-31
2005-10-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks
Interventions
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Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks
Eligibility Criteria
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Inclusion 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 symptomatic CNS metastasis
* No radiation to \> 25% of the marrow containing spaces
* No previous treatment with pemetrexed
* No uncontrolled pleural effusions
* No current breastfeeding
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Walther Cancer Institute
OTHER
Hoosier Cancer Research Network
OTHER
Responsible Party
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Hoosier Oncology Group
Principal Investigators
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Nasser Hanna, M.D.
Role: STUDY_CHAIR
Hoosier Oncology Group, LLC
Locations
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Helen F. Graham Cancer Center
Newark, Delaware, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Community Regional Cancer Center
Indianapolis, Indiana, United States
Arnett Cancer Care
Lafayette, Indiana, United States
Medical Consultants, P.C.
Muncie, Indiana, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Northern Indiana Oncology Associates
South Bend, Indiana, United States
AP&S Clinic
Terre Haute, Indiana, United States
Siteman Cancer Center
St Louis, Missouri, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Countries
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References
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Jalal S, Ansari R, Govindan R, Bhatia S, Bruetman D, Fisher W, Masters G, White A, Stover D, Yu M, Hanna N; Hoosier Oncology Group. Pemetrexed in second line and beyond small cell lung cancer: a Hoosier Oncology Group phase II study. J Thorac Oncol. 2009 Jan;4(1):93-6. doi: 10.1097/JTO.0b013e31818de1e6.
Related Links
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Hoosier Oncology Group Home Page
Other Identifiers
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HOG LUN04-78
Identifier Type: -
Identifier Source: org_study_id
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