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Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
This study has been terminated.
Sponsors and Collaborators: Hoosier Oncology Group
Eli Lilly and Company
Walther Cancer Institute
Information provided by: Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00216216
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: Pemetrexed
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Pemetrexed disodium Pemetrexed
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78)

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: January 2005
Study Completion Date: October 2005
Arms Assigned Interventions
1: Active Comparator
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
Drug: Pemetrexed
Pemetrexed 500 mg/m2 IV q 3 weeks

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216216

Locations
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
AP&S Clinic
Terre Haute, Indiana, United States, 47804
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, United States, 47150
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Northern Indiana Oncology Associates
South Bend, Indiana, United States, 46617
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 Oncology Group
Eli Lilly and Company
Walther Cancer Institute
Investigators
Study Chair: Nasser Hanna, M.D. Hoosier Oncology Group, LLC
  More Information

Hoosier Oncology Group Home Page  This link exits the ClinicalTrials.gov site

Responsible Party: Hoosier Oncology Group ( Nasser Hanna, M.D. )
Study ID Numbers: HOG LUN04-78
Study First Received: September 12, 2005
Last Updated: April 2, 2008
ClinicalTrials.gov Identifier: NCT00216216  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Folic Acid
Pemetrexed
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009