Gemcitabine and/or Erlotinib as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283244
• Other study ID #: LCCC 0512
• Secondary ID: P30CA016086UNC-L
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: July 1, 2016
• Start date: March 2006
• Est. completion date: October 2014

Study information

• Verified date: July 2016
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy.

Secondary

• Determine the response rate in patients receiving these regimens.

• Determine the overall survival rate in patients receiving these regimens.

• Determine the toxicity profile of these regimens in these patients.

• Determine the quality of life of patients receiving these regimens.

OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study. Patients are stratified by gender, smoking status (never or light vs current or former), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II.

• Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.

• Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II.

In all arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage IIIB or IV disease

• Measurable disease by RECIST criteria

• Treated brain metastases allowed provided patient is asymptomatic

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 8.0 g/dL

• AST and ALT = 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 4 times ULN

• Creatinine = 1.5 times ULN

• Bilirubin normal

• No history of severe hypersensitivity to gemcitabine hydrochloride

• No severe comorbid illness

• Able to participate in quality of life assessments

PRIOR CONCURRENT THERAPY:

• Recovered from prior oncologic or other major surgery

• One prior treatment for NSCLC allowed provided it was in the neoadjuvant or adjuvant setting

• At least 1 year since prior treatment in the neoadjuvant or adjuvant setting

• No other concurrent antineoplastic or antitumor agents or therapies, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

• No other concurrent investigational agents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• erlotinib hydrochloride
given orally
• gemcitabine hydrochloride
given IV

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Batte Cancer Center at Northeast Medical Center	Concord	North Carolina
United States	Evanston Hospital	Evanston	Illinois
United States	Cape Fear Valley Medical Center Cancer Center	Fayetteville	North Carolina
United States	Highlands Oncology Group - Fayetteville	Fayetteville	Arkansas
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Kingsport Hematology-Oncology Associates	Kingsport	Tennessee
United States	University of Tennessee Cancer Institute - Memphis	Memphis	Tennessee
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	Summit Cancer Care	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six months	Yes
Secondary	Response rate	The best overall response is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started.	Six months	Yes
Secondary	Overall survival rate	For this study, the surveillance period is 6 weeks after completion of the combined modality portion of the protocol (induction plus concurrent chemotherapy and TCRT for dose escalation purposes but indefinitely for safety purposes	6 weeks	Yes
Secondary	Toxicity	Assessments for treatment toxicity will e done with each cycle	After each cycle/3 weeks	Yes
Secondary	Quality of life	FACT-L will be given to subjects after eacy cycle/3 weeks of treatment and after completion of treatment	After each cycle/3 weeks	Yes