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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

erlotinib hydrochloride

gemcitabine hydrochloride

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

70 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Histologic or cytologic diagnosis of stage NSCLC ECOG Performance Status (PS) 0-2 Absolute Neutrophil Count (ANC) ≥ 1.5 Platelets ≥ 100,000 Hemoglobin ≥ 8.0 g/dl Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 upper limit of institutional normal (ULN) Alkaline phosphatase ≤ 4 x ULN Total Bilirubin below or equal to upper institutional normal limits Serum Creatinine ≤ 1.5 x ULN Patients may have received 1 prior treatment in the adjuvant setting, but time since prior chemotherapy must be ≥1 year. Although the protocol specifically says adjuvant therapy, we believe neoadjuvant is similar and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant (post-operative) therapy are similar and should not be distinguished. Therefore, patients may have received 1 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 Exclusion Criteria Patients with a history of severe hypersensitivity to gemcitabine. Incompletely healed from previous oncologic or other major surgery. Pregnancy or breast feeding (women of childbearing potential are not expected to be enrolled in this study given minimum age) Patients with severe co-morbid illness. Patients unable to participate in the QOL assessments.

Sites / Locations

Highlands Oncology Group - Fayetteville
Summit Cancer Care
Evanston Hospital
Hackensack University Medical Center Cancer Center
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Blumenthal Cancer Center at Carolinas Medical Center
Batte Cancer Center at Northeast Medical Center
Cape Fear Valley Medical Center Cancer Center
Rex Cancer Center at Rex Hospital
Kingsport Hematology-Oncology Associates
University of Tennessee Cancer Institute - Memphis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response Rate

The best overall response (BOR) 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. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Overall Survival

Survival calculated from start of treatment to death from any cause for up to three years.

Toxicity

Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade >=3, treatment related hematologic events (all) and Grade>=3 treatment related non hematologic events that occurred in >=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening.

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

The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores. A best response for TOI-L scores is based on change from baseline and coded as: a change >=+6 "improved", <= -6 "worsened" and otherwise "no change". A best overall score response is coded as: Improved (2 visit resp. of "improved" a min. of 28 days apart w/ no interim "worsened") No change (not "improved;" 2 visit resp. of "no change" or "improved" a min. of 28 days apart w/ no interim "worsened") Worsened (not "improved" or "no change;" 2 consecutive "worsened") Other (none of the above)

Full Information

NCT ID

NCT00283244

First Posted

January 24, 2006

Last Updated

March 9, 2017

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00283244

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm B

Arm Type

Experimental

Arm Description

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

Arm Title

Arm C

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

erlotinib hydrochloride

Other Intervention Name(s)

Tarceva

Intervention Description

given orally

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Other Intervention Name(s)

Gemzar

Intervention Description

given IV

Primary Outcome Measure Information:

Title

Progression-free Survival

Description

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Response Rate

Description

Time Frame

Six months

Title

Overall Survival

Description

Survival calculated from start of treatment to death from any cause for up to three years.

Time Frame

Up to 3 years

Title

Toxicity

Description

Time Frame

After each cycle/3 weeks, up to 3 years

Title

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

Description

Time Frame

After each cycle/3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas E Stinchcombe, MD

Organizational Affiliation

UNC Lineberger Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Highlands Oncology Group - Fayetteville

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Summit Cancer Care

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Evanston Hospital

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201-1781

Country

United States

Facility Name

Hackensack University Medical Center Cancer Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

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

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7295

Country

United States

Facility Name

Blumenthal Cancer Center at Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28232-2861

Country

United States

Facility Name

Batte Cancer Center at Northeast Medical Center

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

Cape Fear Valley Medical Center Cancer Center

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28302-2000

Country

United States

Facility Name

Rex Cancer Center at Rex Hospital

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Kingsport Hematology-Oncology Associates

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

University of Tennessee Cancer Institute - Memphis

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share any individual participant data.

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT00283244

Description

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

Learn more about this trial

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

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