Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC

NCT00283244 | Completed Phase 2 Results DMC

• 3 other identifiers: LCCC 0512P30CA016086UNC-LCCC-0512
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 11

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Six months

Secondary Outcomes (4)

• Response Rate

  Six months

• Overall Survival

  Up to 3 years

• Toxicity

  After each cycle/3 weeks, up to 3 years

• Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L)

  After each cycle/3 weeks

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.

Drug: gemcitabine hydrochloride

Arm B

EXPERIMENTAL

Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.

Drug: erlotinib hydrochloride

Arm C

EXPERIMENTAL

Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily

Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

Interventions

erlotinib hydrochloride DRUG

given orally

Also known as: Tarceva

Arm B; Arm C

gemcitabine hydrochloride DRUG

given IV

Also known as: Gemzar

Arm A; Arm C

Eligibility Criteria

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• prior treatment in the neo-adjuvant setting as well. Treated brain metastases are eligible provided the patient is asymptomatic and meets the above criteria, including PS. Measurable disease by RECIST criteria Ability to give informed consent

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Summit Cancer Care

Savannah, Georgia, 31405, United States

Location

Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, 28025, United States

Location

Cape Fear Valley Medical Center Cancer Center

Fayetteville, North Carolina, 28302-2000, United States

Location

Rex Cancer Center at Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Kingsport Hematology-Oncology Associates

Kingsport, Tennessee, 37660, United States

Location

University of Tennessee Cancer Institute - Memphis

Memphis, Tennessee, 38104, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Thomas E Stinchcombe, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 27, 2006
• Study Start: March 1, 2006
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 24, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)