Phase II Bevacizumab, Gemcitabine and Carboplatin in Newly Diagnosed Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00323869 |
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Recruitment Status :
Completed
First Posted : May 10, 2006
Results First Posted : July 27, 2016
Last Update Posted : September 7, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer Non-small Cell Lung Cancer (NSCLC) | Drug: Bevacizumab Drug: Gemcitabine Drug: Carboplatin | Phase 2 |
This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.
Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma) |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bevacizumab + carboplatin + gemcitabine
Bevacizumab in combination with carboplatin and gemcitabine: •Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles. Carboplatin was administered before the gemcitabine infusion: •Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Bevacizumab was administered 1 hour after end of all chemotherapy infusions: •Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity |
Drug: Bevacizumab
Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody
Other Names:
Drug: Gemcitabine Nucleoside analog
Other Name: Gemzar Drug: Carboplatin Alkylating agent
Other Names:
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- Progression-free Survival (PFS) [ Time Frame: 18 months ]Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
- Response Rate (CR + PR + SD) [ Time Frame: 6 weeks ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE
Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.
- Complete Response (CR) = disappearance of all target lesions
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions
- Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions
- Stable Disease (SD): No significant effect, does not meet criteria for PR or PD.
- Overall Survival (OS) [ Time Frame: 36 months ]To evaluate the safety of the combination regimen.
- Partial Response (PR) [ Time Frame: 6 weeks ]Number of subjects with PR per RECIST criteria
- Complete Response (CR) [ Time Frame: 6 weeks ]Number of subjects with CR per RECIST criteria
- Stable Disease (SD) [ Time Frame: 6 weeks ]Number of subjects with SD per RECIST criteria
- Time-to-First Event [ Time Frame: 18 months ]Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation
- Overall Survival (OS) at 12 Months [ Time Frame: 12 months ]Number of subjects surviving 1 year after treatment initiation
- Overall Survival (OS) at 24 Months [ Time Frame: 24 months ]Number of subjects surviving 2 years after treatment initiation
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria :
- Age 18 or higher
- Life expectancy of at least 3 months
- ECOG Performance status 0 to 1
- Advanced stage non-small cell lung cancer, NSCLC, Stage IIIB with malignant pleural effusion or Stage 4, excluding squamous cell histology, with measurable or evaluable disease
- No prior systemic therapy for advanced NSCLC (prior therapy for early stage disease with one regimen is acceptable if it was completed at least 6 months prior to study entry)
- Palliative radiotherapy to painful bony metastases is permitted prior to study entry if completed prior to initiation of study treatment, and there are no residual sequelae of therapy such as bone marrow suppression
- Willingness to use appropriate contraception to avoid pregnancy during the study
- Leukocytes ≥ 3,000/µL
- Absolute neutrophil count ≥ 1,500/ µL
- Platelets ≥ 100,000/ µL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal
- Creatinine: Within normal institutional limits
- Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
- Ability to sign informed consent
Exclusion Criteria:
- Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed at least 6 months prior to study entry)
- Known brain metastases
- Prior treatment with bevacizumab
- History of allergic reactions
- Sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
- Concomitant chemotherapy, radiotherapy, or investigational agents
- Evidence of bleeding diathesis
- Coagulopathy
- Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
- Pregnant
- Lactating
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures within 7 days prior to day 0
- Fine needle aspirations within 7 days prior to day 0
- Core biopsies within 7 days prior to day 0
- Urine protein: creatinine ratio ≥ 1.0 at screening
- History of abdominal fistula within 6 months prior to Day 0
- Gastrointestinal perforation within 6 months prior to Day 0
- Intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound
- Ulcer
- Bone fracture
- Lung carcinoma of squamous cell histology
- Any histology in close proximity to a major vessel
- Significant cavitation as assessed by treating investigator in consultation with an attending radiologist
- History of hemoptysis (bright red blood of 1/2 teaspoon or more)
- Blood pressure of > 150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade 2 or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Psychiatric illness/social situations that would limit compliance with study requirements
- Another active malignancy except for non-melanoma skin cancers
- Inability to comply with study and/or follow-up procedures
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): NCT00323869
| United States, California | |
| VA Palo Alto Healthcare System | |
| Palo Alto, California, United States, 94304-1290 | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Heather A Wakelee, MD | Stanford University |
| Responsible Party: | Heather Wakelee, Associate Professor of Medicine (Oncology), Stanford University |
| ClinicalTrials.gov Identifier: | NCT00323869 |
| Other Study ID Numbers: |
IRB-03730 96655 ( Other Identifier: Stanford IRB alternate number ) AVF3576s LUN0013 ( Other Identifier: OnCore ) |
| First Posted: | May 10, 2006 Key Record Dates |
| Results First Posted: | July 27, 2016 |
| Last Update Posted: | September 7, 2016 |
| Last Verified: | July 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Bevacizumab Carboplatin 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 |