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

Primary Purpose

Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
Hoosier Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helen F. Graham Cancer Center
  • Medical & Surgical Specialists, LLC
  • Elkhart Clinic
  • Oncology Hematology Associates of SW Indiana
  • Fort Wayne Oncology & Hematology, Inc
  • Center for Cancer Care at Goshen Health System
  • Indiana University Cancer Center
  • Community Regional Cancer Center
  • Arnett Cancer Care
  • Medical Consultants, P.C.
  • Center for Cancer Care, Inc., P.C.
  • Northern Indiana Cancer Research Consortium
  • Northern Indiana Oncology Associates
  • AP&S Clinic
  • Siteman Cancer Center
  • Methodist Cancer Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.

Outcomes

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.

Secondary Outcome Measures

To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival

Full Information

First Posted
September 12, 2005
Last Updated
April 28, 2011
Sponsor
Hoosier Cancer Research Network
Collaborators
Eli Lilly and Company, Walther Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00216216
Brief Title
Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
The results from the interim analysis were not favorable to continue this trial.
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoosier Cancer Research Network
Collaborators
Eli Lilly and Company, Walther Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 mg/m2 IV q 3 weeks
Primary Outcome Measure Information:
Title
- 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 Measure Information:
Title
To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Hanna, M.D.
Organizational Affiliation
Hoosier Oncology Group, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical & Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Elkhart Clinic
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Fort Wayne Oncology & Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Center for Cancer Care at Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46527
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Regional Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Arnett Cancer Care
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Medical Consultants, P.C.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Center for Cancer Care, Inc., P.C.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Northern Indiana Oncology Associates
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
AP&S Clinic
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Siteman Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19096313
Citation
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.
Results Reference
result
Links:
URL
http://hoosieroncologygroup.org
Description
Hoosier Oncology Group Home Page

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

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