First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC

NCT00456261 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 139
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 18

Brief Summary

This trial will look at 2 different drug combinations that have well known safety profiles and are known to be active against non small cell lung cancer and combine them with bevacizumab, an experimental drug that has shown effectiveness when added to other drug combinations for advanced non-small cell lung cancer. The primary objective in this study is to see how well this combination of drugs keeps the cancer from getting worse in this elderly population of non-small cell lung cancer patients.

Conditions

Lung Cancer

Keywords

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

  Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.

  From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months

Secondary Outcomes (2)

• Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

  From date of treatment initiation to end of study treatment up to 18 months

• Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

  From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 months

Study Arms (2)

Cohort A

EXPERIMENTAL

Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.

Drug: Pemetrexed; Drug: Gemcitabine; Drug: Bevacizumab

Cohort B

EXPERIMENTAL

Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.

Drug: Pemetrexed; Drug: Bevacizumab; Drug: Carboplatin

Interventions

Pemetrexed DRUG

pemetrexed 500 mg/m2

Also known as: Alimta

Cohort A; Cohort B

Gemcitabine DRUG

gemcitabine 1500 mg/m2

Also known as: Gemzar

Cohort A

Bevacizumab DRUG

bevacizumab 10mg/kg bevacizumab 15mg/kg

Also known as: Avastin

Cohort A; Cohort B

Carboplatin DRUG

carboplatin AUC=5

Also known as: Paraplatin

Cohort B

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed non-small cell bronchogenic carcinoma, (adenocarcinoma, or large cell carcinoma)
• Patients who have newly diagnosed unresectable stage III or stage IV disease are eligible.
• Must be at least 70 years of age
• Must have measurable disease by CT scan
• Must be able to be up and about and care for themselves
• May not have received prior treatment for stage III or IV disease
• Must have adequate white and red blood cells and platelets.
• Must be able to take Vitamin B12, Folic Acid and dexamethasone as stated in the study
• Must be able to understand the nature of this study and give written informed consent
• Adequate liver and kidney function

You may not qualify if:

• Past or current history of cancer with the exception of treated non- melanoma skin cancer or carcinoma in-situ of the cervix, or other cancers cured by local therapy alone and have been disease free for five years
• Female patients who are pregnant or are lactating are ineligible
• History of unstable angina or myocardial infarction within 6 months prior to beginning bevacizumab
• Brain metastasis - cancer that has spread to the brain
• Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks of beginning bevacizumab or anticipation of need for major surgical procedure during the course of the study
• Full-dose oral or by vein anticoagulation or receiving anti-clotting therapy within 10 days of starting treatment
• Serious nonhealing wound, ulcer, or bone fracture
• Bleeding or clotting disorders
• Uncontrolled high blood pressure or serious heart arrhythmia requiring medication
• History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 6 months prior to beginning bevacizumab
• Chronic non-steroidal anti-inflammatory use is not allowed on study
• History of stroke or TIAs within the last 6 months

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (18)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36207, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Wellstar Cancer Research

Marietta, Georgia, 30060, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Graves-Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Mercy Hospital

Portland, Maine, 04101, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Cancer Care of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Associates in Hematology Oncology

Chattanooga, Tennessee, 37404, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related Publications (1)

• Spigel DR, Hainsworth JD, Shipley DL, Ervin TJ, Kohler PC, Lubiner ET, Peyton JD, Waterhouse DM, Burris HA 3rd, Greco FA. A randomized phase II trial of pemetrexed/gemcitabine/bevacizumab or pemetrexed/carboplatin/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. J Thorac Oncol. 2012 Jan;7(1):196-202. doi: 10.1097/JTO.0b013e3182307efe.

  PMID: 21900836 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Gemcitabine; Bevacizumab; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• David R Spigel, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2012
• Last Updated: May 3, 2022
• Results First Posted: February 27, 2013

Record last verified: 2022-04

Locations

US (18)