First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
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| ClinicalTrials.gov Identifier: NCT00456261 |
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Recruitment Status :
Completed
First Posted : April 4, 2007
Results First Posted : February 27, 2013
Last Update Posted : February 27, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: Pemetrexed Drug: Gemcitabine Drug: Bevacizumab Drug: Carboplatin | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | March 2007 |
| Actual Primary Completion Date : | February 2010 |
| Actual Study Completion Date : | September 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A
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.
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Drug: Pemetrexed
pemetrexed 500 mg/m2
Other Name: Alimta Drug: Gemcitabine gemcitabine 1500 mg/m2
Other Name: Gemzar Drug: Bevacizumab bevacizumab 10mg/kg bevacizumab 15mg/kg
Other Name: Avastin |
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Experimental: Cohort B
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.
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Drug: Pemetrexed
pemetrexed 500 mg/m2
Other Name: Alimta Drug: Bevacizumab bevacizumab 10mg/kg bevacizumab 15mg/kg
Other Name: Avastin Drug: Carboplatin carboplatin AUC=5
Other Name: Paraplatin |
- 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 Frame: 18 months ]Defined as the interval between the date of treatment initiation and the date of progressive disease
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]
- Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456261
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| Principal Investigator: | David R Spigel, MD | SCRI Development Innovations, LLC |
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00456261 |
| Other Study ID Numbers: |
SCRI LUN 139 |
| First Posted: | April 4, 2007 Key Record Dates |
| Results First Posted: | February 27, 2013 |
| Last Update Posted: | February 27, 2013 |
| Last Verified: | January 2013 |
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Non Small Cell Lung Cancer |
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Bevacizumab Carboplatin Pemetrexed Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |