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Paclitaxel, Carboplatin, and Bevacizumab With or Without Cixutumumab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overNCINCI-2011-01960
CDR0000651469, ECOG-E3508, E3508, U10CA021115, NCT00955305

Trial Description

Summary

This randomized phase II trial is studying giving paclitaxel and carboplatin together with bevacizumab to see how well it works when given with or without cixutumumab in treating patients with stage IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate the progression-free survival with the combination of carboplatin, paclitaxel, and bevacizumab with vs without cixutumumab in patients with stage IV or recurrent non-squamous, non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To evaluate overall survival and response rate of the above combination in patients with non-squamous, advanced non-small cell lung cancer.

II. To evaluate the toxicities of the above combination in patients with non-squamous advanced non-small cell lung cancer.

OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.

ARM II: Patients receive paclitaxel, carboplatin, and bevacizumab as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15.In both arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous, non-small celllung cancer (NSCLC), including any of the following subtypes*:
  • Adenocarcinoma
  • Large cell
  • Bronchioloalveolar
  • NSCLC not otherwise specified
  • Advanced disease, as defined by any of the following:
  • Stage IV (M1a or M1b)* disease based on the TNM staging system
  • Recurrent disease after prior radiotherapy or surgery
  • Measurable disease, as defined by RECIST (PET and the PET portion of PET/CT are not acceptable methods of evaluation for response)
  • No prior radiotherapy to the only area of measurable disease unless there is progression of disease documented by physical examination, imaging tests, or pathology in this region
  • 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 tumor progression in the brain
  • Patients must undergo head CT scan or MRI within 4 weeks prior to randomization for evaluation
  • At least 6 weeks since prior craniotomy and ≥ 4 weeks since prior radiotherapy
  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin normal
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Fasting blood glucose normal (fasting < 120 mg/dL or below ULN)
  • AST and ALT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • Urine protein by dipstick ≤ 1+ (within 2 weeks of randomization) OR urine protein:creatinine < 1.0
  • INR < 1.5 or PTT normal
  • Neuropathy ≤ CTCAE grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No prior allergic reaction to compounds of chemical or biological composition similar to those of cixutumumab
  • No known hypersensitivity to any component of bevacizumab
  • No poorly controlled diabetes mellitus
  • History of diabetes mellitus allowed, provided blood glucose is within normal range
  • No history of other invasive malignancies unless there is no active disease and all treatment has been completed > 3 years prior to study
  • Patients with history of in-situ malignancies and curatively resected nonmelanomatous skin cancer are allowed
  • Patients with a history of breast cancer (without evidence of disease for ≥ 3 years) who recently completed adjuvant hormonal therapy < 3 years from the date of registration are eligible
  • No history of thrombotic or hemorrhagic disorders
  • No history of bleeding diathesis or coagulopathy
  • No bleeding ≥ grade 2 (CTCAE version 3) requiring intervention within the past 4weeks
  • No history of gross hemoptysis (defined as > ½ teaspoon of bright red blood)
  • No history of hypertensive crisis or hypertensive encephalopathy
  • History of hypertension allowed provided it is well-controlled (< 150/90 mm Hg) by stable anti-hypertensive therapy
  • None of the following conditions within the past 6 months:
  • Abdominal fistula
  • Gastrointestinal perforation
  • Intra-abdominal abscess
  • Myocardial infarction
  • Stroke
  • Any CNS cerebrovascular ischemia
  • New York Heart Association class II-IV congestive heart failure or severe heart failure
  • Unstable or symptomatic angina pectoris
  • Significant vascular disease
  • Symptomatic peripheral vascular disease
  • No ongoing, serious cardiac arrhythmia requiring medication
  • No ongoing, active infection or fever
  • No co-existing medical condition, psychiatric illness or limitations that would interfere with compliance of study requirements
  • No serious non-healing wound, ulcer, bone fracture within the past 4 weeks
  • No other concurrent anticancer therapy (e.g., biologic agents, chemotherapy, or radiotherapy)
  • No prior chemotherapy or biologic or molecular targeted therapy for advanced NSCLC
  • No prior cixutumumab or another IGF-IR inhibitor
  • At least 3 weeks since prior radiotherapy and recovered
  • More than 1 year since prior chemotherapy and/or biological or molecular targeted therapy as part of initial potentially curative therapy (i.e., one regimen of induction and/or adjuvant and/or concurrent chemoradiotherapy)
  • More than 4 weeks since prior and no concurrent major surgical procedure
  • More than 7 days since prior minor surgical procedure
  • More than 1 week since prior and no concurrent daily treatment with acetylsalicylic acid (> 325 mg/day) or other non-steroidalanti-inflammatory agents
  • More than 1 week since prior and no concurrent dipyridamole (Persantine), ticlopidine (Ticlid),clopidogrel (Plavix), and/or cilostazol (Pletal)
  • No concurrent therapeutic anticoagulation, except prophylactic anticoagulation of venous access device
  • No concurrent combination antiretroviral therapy in HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Athanassios (Ethan) ArgirisPrincipal Investigator

Trial Sites

U.S.A.
Connecticut
  Torrington
 Connecticut Oncology & Hematology - Torrington
 Michael C. Magnifico Ph: 860-482-5384
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
  Wynnewood
 CCOP - Main Line Health
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
 Lankenau Cancer Center at Lankenau Hospital
 Paul B. Gilman Ph: 484-476-2649
  Email: wellenbachj@mlhs.org
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Wisconsin
  Appleton
 Fox Valley Hematology and Oncology - East Grant Street
 Avi Bar-Lev Ph: 920-749-1171

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00955305
ClinicalTrials.gov processed this data on April 10, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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