Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Disease Progression

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Erlotinib Hydrochloride

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

150mg po on days 15-28 of each 4 week cycle

erlotinib [Tarceva]

1250mg/m2/day on days 1 and 8 of each 4 week cycle

gemcitabine

1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle

Clinical Trials

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.

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.

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.

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.

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.

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.

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 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.

Hoffmann-La Roche

All participants who received at least 1 dose/infusion of study treatment and had at least 1 safety assessment performed after BL were included in the safety analysis.

Participants received gemcitabine, 1000 mg/m\^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.

Gemcitabine Monotherapy

Participants received gemcitabine, 1250 mg/m\^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

Gemcitabine + Erlotinib

Total

Age, Continuous

Sex: Female, Male

Full Analysis Set (FAS) (following an intent-to-treat principle): all randomized participants.

Due to slower than expected recruitment, this study was stopped after 54 patients had been enrolled.

Medical Communications

Percentage of Participants With Disease Progression or Death

Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0

Difference between treatment groups in PFS

Week 8

Week 16

Percentage of Participants With Non-Progression at Weeks 8 and 16

Gemcitabine+ Erlotinib

Percentage of Participants Who Died

Difference between treatment groups in OS

Overall Survival (OS)

Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.

Duration of Response

Participants received gemcitabine, 1000 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.

Participants received gemcitabine, 1250 mg/m\^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial