A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

NCT01196078 | Completed Phase 4 Results

• 1 other identifier: ML20322
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)

  CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.

  Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

Secondary Outcomes (11)

• Percentage of Participants Achieving Disease Control

  Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

• Duration of Response Among Participants Who Achieved Either a CR or PR

  Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up

• Percentage of Participants With Disease Progression

  Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

• Time to Disease Progression

  Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

• Overall Survival: Percentage of Participants With an Progressive Disease or Death

  Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment

Study Arms (2)

1

EXPERIMENTAL

Drug: erlotinib [Tarceva]

2

ACTIVE COMPARATOR

Drug: vinorelbine

Interventions

erlotinib [Tarceva] DRUG

150 mg, orally once a day for up to 6 cycles of 21 days each

1

vinorelbine DRUG

60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adult patients, \>=70 years of age
• Non-small cell lung cancer
• Naive to prior chemotherapy or specific immunotherapy
• Presence of at least 1 measurable lesion

You may not qualify if:

• Active non-controlled infection or disease
• CNS metastases
• Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Vinorelbine

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; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: February 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-06

Locations

TW (1)