Study Stopped
The results from the interim analysis were not favorable to continue this trial.
Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78)
1 other identifier
interventional
43
1 country
16
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2005
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMay 2, 2011
April 1, 2011
9 months
September 12, 2005
April 28, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
- 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.
12 months
Secondary Outcomes (1)
To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival
12 months
Study Arms (1)
1
ACTIVE COMPARATORPemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoosier Cancer Research Networklead
- Eli Lilly and Companycollaborator
- Walther Cancer Institutecollaborator
Study Sites (16)
Helen F. Graham Cancer Center
Newark, Delaware, 19713, United States
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401, United States
Elkhart Clinic
Elkhart, Indiana, 46515, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Community Regional Cancer Center
Indianapolis, Indiana, 46256, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Northern Indiana Oncology Associates
South Bend, Indiana, 46617, United States
AP&S Clinic
Terre Haute, Indiana, 47804, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Related Publications (1)
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.
PMID: 19096313RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
May 2, 2011
Record last verified: 2011-04