Status:
TERMINATED
Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Eli Lilly and Company
Walther Cancer Institute
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 acti...
Detailed Description
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00216216
Start Date
January 1 2005
End Date
October 1 2005
Last Update
May 2 2011
Active Locations (16)
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1
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
2
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
3
Elkhart Clinic
Elkhart, Indiana, United States, 46515
4
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714