A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887549
First received: April 23, 2009
Last updated: June 7, 2012
Last verified: June 2012

April 23, 2009
June 7, 2012
April 2009
July 2010   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy) ] [ Designated as safety issue: No ]
PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.
Correlation between TS expression and Progression Free Survival. [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887549 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Tumor Response (Tumor Response Rate) [ Time Frame: Baseline to disease progression (up to 20 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST 1.0) 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. Percentage of participants with tumor response was determined by the number of participants with PR or CR (confirmed or not) divided by the total number of treated participants multiplied by 100.
  • Percentage of Participants With Concordance Between Local and Central Histological Diagnosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A centralized pathology review on all enrolled participants was performed to confirm the histological diagnosis performed at the site. Upon review of the local diagnosis obtained at the respective site, the central reviewer established whether or not there was an agreement between the local and central diagnosis. The percentage of participants with concordance was defined as the number of participants for which there was an agreement divided by the number of treated participants (concordance rate) multiplied by 100.
  • Percentage of Participants Surviving at 18 Months (Overall Survival Rate) [ Time Frame: Baseline to date of death (up to 24.5 months) ] [ Designated as safety issue: No ]
    The percentage of participants surviving at 18 months was defined as the number of treated participants who had not died prior to 18 months from the date of their first dose divided by the total number of treated participants multiplied by 100. For participants who are alive, overall survival was censored at the last contact.
  • Tumour response rate [ Time Frame: baseline to disease progression ] [ Designated as safety issue: No ]
  • Concordance between local and central histology review [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: baseline to 18 months after last patient entry ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer
An Exploratory, Prospective Phase II Study to Investigate Progression-Free Survival, Response and Overall Survival Seen With Pemetrexed/Cisplatin and the Role of Thymidylate Synthase Expression

Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.

TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: pemetrexed
    Induction Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
    Other Names:
    • Alimta
    • LY231514
  • Drug: cisplatin
    Induction Therapy: 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles
Experimental: Pemetrexed
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2011
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have Stage 3B or 4 Non-Small Cell Lung Cancer of the non- squamous type
  • Patients must at least be able to be physically mobile, take care of yourself and be able to perform light activities such as light housework or office work
  • Patients must not have had previous chemotherapy treatment for lung cancer
  • Patients must not have had radiotherapy in the last 30 days
  • Patients must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computed tomography (CT) scan
  • Patients' test results assessing the function of their blood forming tissue, kidneys, liver and lungs are satisfactory
  • Women must be sterile, postmenopausal or on contraception and men must be sterile or on contraception

Exclusion Criteria:

  • Patients cannot have received other investigational drugs within the last 30 days
  • Patients cannot have any serious, uncontrolled medical condition that might compromise their ability to take part in the study safely
  • Patients cannot have a current second primary malignant tumor
  • Patients cannot be having current treatment with any other anti-tumor therapy
  • Patients cannot have had a yellow fever vaccination within 30 days of enrolment
  • Patients who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
  • Patients who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
  • Patients who are pregnant or breastfeeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00887549
13069, H3E-BP-JMIK
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP