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

This study has been terminated.
(Stopped early due to low enrollment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356525
First received: July 24, 2006
Last updated: August 9, 2010
Last verified: August 2010
  Purpose

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

Condition Intervention Phase
Lung Neoplasms
Drug: pemetrexed
Drug: gemcitabine
Drug: carboplatin
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: baseline to time of response (up to 17.5 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to trial termination (17.5 months) ] [ Designated as safety issue: No ]
    Overall survival is the number of participants who were alive when the trial was terminated.

  • Time to Progressive Disease [ Time Frame: baseline to measured progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: time of response to progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 17.5 months) ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: September 2006
Study Completion Date: April 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • LY231514
  • Alimta
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • LY188011
  • Gemzar
Experimental: Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
  • LY231514
  • Alimta
Experimental: One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
Drug: carboplatin
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
  • LY231514
  • Alimta
Experimental: One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • LY231514
  • Alimta
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • LY188011
  • Gemzar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356525

Locations
United States, Florida
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, United States, 33179
United States, Illinois
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, United States, 60201
United States, Kansas
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, United States, 67214
United States, Minnesota
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, United States, 55455
United States, Missouri
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.
Saint Louis, Missouri, United States, 63110
United States, Nebraska
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, United States, 68114
United States, North Carolina
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, United States, 27599
United States, Tennessee
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, United States, 37404
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, United States, 38120
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, United States, 37203
United States, Texas
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, United States, 77060
Brazil
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, Brazil, 95070560
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, Brazil, 90430-090
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 Andre, Brazil, 09090780
India
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, India, 560 029
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, India, 400016
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, India, 695011
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00356525     History of Changes
Other Study ID Numbers: 9934, H3E-US-S082
Study First Received: July 24, 2006
Results First Received: June 8, 2009
Last Updated: August 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 22, 2014