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

NCT00940875 | Terminated Phase 2 Results

• 1 other identifier: ML22429
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Disease Progression or Death

  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.

  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).

• PFS

  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.

  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)

Secondary Outcomes (5)

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

  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).

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

  Weeks 8 and 16

• Percentage of Participants Who Died

  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.

• Overall Survival (OS)

  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.

• Duration of Response

  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.

Study Arms (2)

1

EXPERIMENTAL

Drug: erlotinib [Tarceva]; Drug: gemcitabine

2

ACTIVE COMPARATOR

Drug: gemcitabine

Interventions

erlotinib [Tarceva] DRUG

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

1

gemcitabine DRUG

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

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• active brain metastasis or spinal cord suppression;
• unstable systemic disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Unknown Facility

Port Macquarie, New South Wales, 2444, Australia

Location

Unknown Facility

Randwick, New South Wales, 2031, Australia

Location

Unknown Facility

Sydney, New South Wales, 2139, Australia

Location

Unknown Facility

Sydney, New South Wales, 2747, Australia

Location

Unknown Facility

Tweed Heads, New South Wales, NSW 2485, Australia

Location

Unknown Facility

Wollongong, New South Wales, 2500, Australia

Location

Unknown Facility

Brisbane, Queensland, 4029, Australia

Location

Unknown Facility

Greenslopes, Queensland, 4120, Australia

Location

Unknown Facility

Woolloongabba, Queensland, 4102, Australia

Location

Unknown Facility

Richmond, South Australia, 3121, Australia

Location

Unknown Facility

Terrace Gardens, South Australia, 5065, Australia

Location

Unknown Facility

Hobart, Tasmania, 7000, Australia

Location

Unknown Facility

Bendigo, Victoria, 3550, Australia

Location

Unknown Facility

Heidelberg, Victoria, 3084, Australia

Location

Unknown Facility

Melbourne, Victoria, 3002, Australia

Location

Unknown Facility

Wodonga, Victoria, 3690, Australia

Location

Unknown Facility

Fremantle, Western Australia, 6160, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 2, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-04

Locations

AU (17)