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Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

Primary Purpose

Lung Neoplasms

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

pemetrexed

gemcitabine

carboplatin

Pemetrexed

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

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

Inclusion Criteria: You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy. You have good kidney, liver, and bone marrow organ function. You are fully active or able to carry out light work such as housework or office work. Exclusion Criteria: You have received pemetrexed or gemcitabine in the past for lung cancer You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past You are unable to take corticosteroid drugs like dexamethasone You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Less Than One Year: Pemetrexed

Less Than One Year: Pemetrexed + Gemcitabine

One Year or Greater: Pemetrexed + Carboplatin

One Year or Greater: Pemetrexed + Gemcitabine

Arm Description

Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy

Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Outcomes

Primary Outcome Measures

Objective Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Secondary Outcome Measures

Overall Survival

Overall survival is the number of participants who were alive when the trial was terminated.

Time to Progressive Disease

Duration of Response

Time to Treatment Failure

Full Information

NCT ID

NCT00356525

First Posted

July 24, 2006

Last Updated

August 9, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00356525

Brief Title

Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

Official Title

Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Terminated

Why Stopped

Stopped early due to low enrollment

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to help answer: Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Less Than One Year: Pemetrexed

Arm Type

Experimental

Arm Description

Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy

Arm Title

Less Than One Year: Pemetrexed + Gemcitabine

Arm Type

Experimental

Arm Description

Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy

Arm Title

One Year or Greater: Pemetrexed + Carboplatin

Arm Type

Experimental

Arm Description

Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Arm Title

One Year or Greater: Pemetrexed + Gemcitabine

Arm Type

Experimental

Arm Description

Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

LY188011, Gemzar

Intervention Description

1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

LY231514, Alimta

Intervention Description

500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression

Primary Outcome Measure Information:

Title

Objective Tumor Response

Description

Time Frame

baseline to time of response (up to 17.5 months)

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival is the number of participants who were alive when the trial was terminated.

Time Frame

baseline to trial termination (17.5 months)

Title

Time to Progressive Disease

Time Frame

baseline to measured progressive disease (up to 17.5 months)

Title

Duration of Response

Time Frame

time of response to progressive disease (up to 17.5 months)

Title

Time to Treatment Failure

Time Frame

baseline to stopping treatment (up to 17.5 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Miami

State/Province

Florida

ZIP/Postal Code

33179

Country

United States

Facility Name

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77060

Country

United States

Facility Name

City

Caxias Do Sul

ZIP/Postal Code

95070560

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90430-090

Country

Brazil

Facility Name

City

Santo Andre

ZIP/Postal Code

09090780

Country

Brazil

Facility Name

City

Bangalore

ZIP/Postal Code

560 029

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400016

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695011

Country

India

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

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