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Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Eli Lilly and Company
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network

Study Description
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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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Pemetrexed Phase 2

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 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
 Drug: Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Hoosier Cancer Research Network
Eli Lilly and Company
Walther Cancer Institute
Investigators
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Study Chair: Nasser Hanna, M.D. Hoosier Oncology Group, LLC
More Information
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Additional Information:

Publications of Results:

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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
Additional relevant MeSH terms:
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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