Status:
TERMINATED
Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Large Cell Lung Carcinoma
Lung Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab (CPB) work when given with or without cixutumumab in treating patients with non-small cell lung cancer that is ...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the progression-free survival with the combination of carboplatin, paclitaxel, and bevacizumab, and +/- IMC-A12 (cixutumumab) in patients with advanced, non-squamou...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed with non-squamous, non-small cell lung cancer (NSCLC)
- Advanced NSCLC defined as either recurrent disease after prior radiation or surgery or stage IV (M1a or M1b) based on the TNM staging system (American Joint Committee on Cancer \[AJCC\] 2009)
- Measurable disease as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). All sites of disease (of target and non-target disease sites) must be obtained within 4 weeks prior to randomization
- A head computed tomography (CT) or magnetic resonance imaging (MRI) required within 4 weeks prior to randomization
- Prior radiation therapy (RT) is allowed if it has been completed 3 weeks prior to randomization and patient has recovered from any adverse events related to RT
- Brain metastases are allowed, provided they have been treated with surgery and/or radiotherapy, the patient is neurologically stable, and repeat brain imaging shows no progression in the brain; at least 6 weeks should have elapsed from the time of craniotomy and at least 4 weeks from radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count (ANC) ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin within institutional upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 x ULN
- Fasting blood glucose within normal range (fasting \< 120 mg/dL or below ULN)
- Alkaline phosphatase (ALP) ≤ 3 x ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Urine dipstick must be ≤ 0-1+ within 2 weeks (14 days) of randomization; if urine dipstick result is \> 1+, a calculation of urine protein creatinine (UPC) ratio is required; patients must have a UPC ratio \< 1.0 to participate in the study
- Neuropathy, if present at baseline, must be ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Patients with a history of hypertension must be well-controlled (≤ 150/90) on a stable regimen of anti-hypertensive therapy
- Women of childbearing potential and sexually active males should use an accepted and effective method of contraception while on treatment and for 3 months thereafter
Exclusion
- Prior chemotherapy or biologic/molecular targeted therapy for advanced NSCLC. Prior chemotherapy and/or biological/molecular targeted therapy as part of initial potentially curative therapy (one regimen of induction and/or adjuvant and/or concurrent chemoradiotherapy) was allowed provided it had been completed 1 year or more prior to randomization
- Prior treatment with IMC-A12 or another insulin-like growth factor 1 receptor (IGF-1R) inhibitor
- Patients on therapeutic anticoagulation; patient's international normalized ratio (INR) must be ≤ 1.5 or partial thromboplastin time (PTT) ≤ upper limits of normal within 2 weeks prior to randomization to be eligible; prophylactic anticoagulation of venous access devices is allowed provided the above criteria have been met
- Prior allergic reaction to compounds of chemical or biologic composition similar to those of IMC-A12
- Hypersensitivity to any component of bevacizumab
- Poorly controlled diabetes mellitus
- History of other invasive malignancies unless there is no active disease and all treatment has been completed ≥ 3 years prior to randomization; patients with history of in-situ malignancies and curatively resected nonmelanomatous skin cancer are eligible
- History of thrombotic or hemorrhagic disorders
- History of bleeding diathesis or coagulopathy
- ≥ grade 2 bleeding or any bleeding requiring intervention within 4 weeks prior to randomization
- History of gross hemoptysis (defined as ≥ 1/2 teaspoon of bright red blood)
- Any of the following within 6 months prior to randomization:
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess
- Previous myocardial infarction
- History of any central nervous system (CNS) cerebrovascular ischemia
- New York Heart Association (NYHA) \> class II congestive heart failure or severe heart failure
- Unstable or symptomatic angina pectoris
- History of stroke
- Significant vascular disease
- Symptomatic peripheral vascular disease
- Ongoing, serious cardiac arrhythmia requiring medication at time of randomization
- Ongoing, active infection or ongoing fever at the time of randomization or any co-existing medical condition, psychiatric illness or limitations that would interfere with compliance of study requirements
- History of hypertensive crisis or hypertensive encephalopathy
- Any of the following within 4 weeks prior to randomization: a serious non-healing wound, ulcer, bone fracture, or major surgical procedure
- Anticipated major surgical procedure(s) during the course of the study
- Receiving daily treatment with aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function for chronic conditions; patients must not be receiving treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal); if patient was receiving any of the following: aspirin (\> 325 mg/day), NSAID, and/or anti-platelet drugs, patient must have discontinued its use ≥ 1 week prior to randomization
- Pregnant or breast-feeding
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00955305
Start Date
March 1 2010
End Date
November 1 2016
Last Update
June 6 2018
Active Locations (165)
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1
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
2
Boulder Community Hospital
Boulder, Colorado, United States, 80301
3
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
4
Porter Adventist Hospital
Denver, Colorado, United States, 80210