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

NCT00356525 | Terminated Phase 2 Results

• 2 other identifiers: 9934H3E-US-S082
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 17

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

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to time of response (up to 17.5 months)

Secondary Outcomes (4)

• Overall Survival

  baseline to trial termination (17.5 months)

• Time to Progressive Disease

  baseline to measured progressive disease (up to 17.5 months)

• Duration of Response

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

• Time to Treatment Failure

  baseline to stopping treatment (up to 17.5 months)

Study Arms (4)

Less Than One Year: Pemetrexed

EXPERIMENTAL

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

Drug: pemetrexed; Drug: gemcitabine

Less Than One Year: Pemetrexed + Gemcitabine

EXPERIMENTAL

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

Drug: Pemetrexed

One Year or Greater: Pemetrexed + Carboplatin

EXPERIMENTAL

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

Drug: carboplatin; Drug: Pemetrexed

One Year or Greater: Pemetrexed + Gemcitabine

EXPERIMENTAL

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

Drug: pemetrexed; Drug: gemcitabine

Interventions

Pemetrexed DRUG

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

Also known as: LY231514, Alimta

Less Than One Year: Pemetrexed; One Year or Greater: Pemetrexed + Gemcitabine

gemcitabine DRUG

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

Also known as: LY188011, Gemzar

Less Than One Year: Pemetrexed; One Year or Greater: Pemetrexed + Gemcitabine

carboplatin DRUG

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

One Year or Greater: Pemetrexed + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (17)

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.

Miami, Florida, 33179, United States

Location

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.

Evanston, Illinois, 60201, United States

Location

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.

Wichita, Kansas, 67214, United States

Location

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.

Minneapolis, Minnesota, 55455, United States

Location

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.

St Louis, Missouri, 63110, United States

Location

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.

Omaha, Nebraska, 68114, United States

Location

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.

Chapel Hill, North Carolina, 27599, United States

Location

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.

Chattanooga, Tennessee, 37404, United States

Location

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.

Memphis, Tennessee, 38120, United States

Location

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.

Nashville, Tennessee, 37203, United States

Location

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.

Houston, Texas, 77060, United States

Location

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.

Caxias do Sul, 95070560, Brazil

Location

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.

Porto Alegre, 90430-090, Brazil

Location

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.

Santo André, 09090780, Brazil

Location

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.

Bangalore, 560 029, India

Location

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.

Mumbai, 400016, India

Location

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.

Trivandrum, 695011, India

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pemetrexed; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Limitations and Caveats

The trial terminated early due to slow enrollment. Secondary outcomes were not analyzed due to insufficient data. Original results reported were interim analyses. Results have now been updated with final data.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: April 1, 2009
• Last Updated: August 17, 2010
• Results First Posted: July 29, 2009

Record last verified: 2010-08

Locations

BR (3); US (11); IN (3)