A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Study was stopped due to slower than expected recruitment.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940875
First received: July 6, 2009
Last updated: April 1, 2015
Last verified: April 2015

July 6, 2009
April 1, 2015
June 2009
September 2011   (final data collection date for primary outcome measure)
  • Percentage of Participants With Disease Progression or Death [ Time Frame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant). ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.
  • PFS [ Time Frame: BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years) ] [ Designated as safety issue: No ]
    The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.
Progression free survival [ Time Frame: tumour assessment after every 2nd 4-week cycle ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00940875 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0 [ Time Frame: BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant). ] [ Designated as safety issue: No ]
    As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.
  • Percentage of Participants With Non-Progression at Weeks 8 and 16 [ Time Frame: Weeks 8 and 16 ] [ Designated as safety issue: No ]
    Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.
  • Percentage of Participants Who Died [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years. ] [ Designated as safety issue: No ]
    OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.
  • Duration of Response [ Time Frame: BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years. ] [ Designated as safety issue: No ]
    Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.
  • Overall response rate,disease control rate,duration of response,overall survival [ Time Frame: tumour assessment after every 2nd 4-week cycle, follow-up for survival at least 12 months ] [ Designated as safety issue: No ]
  • SAEs, AEs, laboratory parameters, vital signs, further/second line treatment. [ Time Frame: Throughout study, laboratory parameters assessed days 1,8,15 and 22 of cycles 1+2, days 1,8 and 15 of cycles 3-6 and every 4 weeks thereafter ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
A Randomized, Open-label Study of the Effect of First Line Treatment With Tarceva in Sequential Combination With Gemcitabine, Compared to Gemcitabine Monotherapy, on Progression-free Survival in Elderly or ECOG PS of 2 Patients With Advanced Non-small Cell Lung Cancer.

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: erlotinib [Tarceva]
    150mg po on days 15-28 of each 4 week cycle
  • Drug: gemcitabine
    1250mg/m2/day on days 1 and 8 of each 4 week cycle
  • Drug: gemcitabine
    1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
  • Experimental: 1
    Interventions:
    • Drug: erlotinib [Tarceva]
    • Drug: gemcitabine
  • Active Comparator: 2
    Intervention: Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
54
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=70 years of age or with ECOG PS of 2;
  • advanced (stage IIIB or IV)non-small cell lung cancer;
  • no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion Criteria:

  • active brain metastasis or spinal cord suppression;
  • unstable systemic disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00940875
ML22429
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2015

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