Clinical trial NCT00456261: First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Non Small Cell Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Eli Lilly and Company
First posted: 2007-04-04
Enrollment: 110
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Patients in this study will be assigned to one of 2 treatment groups. The selection of the treatment groups will be done randomly by a computer.

The first group, 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.

The second group, 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.

In both regimens vitamin B12 injections and Folic Acid pills will be given to reduce the occurrence of side effects from the treatment.

Each patient's disease will be evaluated at intervals by the proper scans or X-rays to see how well the cancer is responding to the treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Please Note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: From date of treatment initiation to end of study treatment up to 18 months
measure: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
timeFrame: 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
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Northeast Alabama Regional Medical Center
state: Alabama
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Cancer Care and Research
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Cancer Research
state: Georgia
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Asheville
country: United States
facility: Cancer Care of Western North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Associates in Hematology Oncology
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.