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A+C in Metastatic Lung Adenocarcinoma Cancer

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ClinicalTrials.gov Identifier: NCT02946359
Recruitment Status : Unknown
Verified November 2016 by yihu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : October 27, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
yihu, Chinese PLA General Hospital

Brief Summary:
This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Metastatic Drug: Crizotinib, bevacizumab Phase 2

Detailed Description:
This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification. Patients with locally advanced or metastatic NSCLC(Stage ⅢB/ⅢC/Ⅳ) with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for ALK、MET and ROS1 by FISH or IHC or NGS to detect MET amplification or ALK translocation or ROS1 translocation After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or ALK translocation or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o and bevacizumab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crizotinib Combined With Bevacizumab as First-line Therapy in Metastatic Lung Adenocarcinoma Cancer With ALK Translocation or MET Amplification or ROS1 Translocation (CAMAR)
Study Start Date : July 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with ALK translocation
Treatment-naive lung adenocarcinoma cancer patients with ALK translocation with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal
Drug: Crizotinib, bevacizumab
Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered
Other Name: XALKORI,AVASTIN

Experimental: Patients with ROS1 translocation
Treatment-naive lung adenocarcinoma cancer patients with ROS1 translocation with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal
Drug: Crizotinib, bevacizumab
Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered
Other Name: XALKORI,AVASTIN

Experimental: Patients with MET amplification
Treatment-naive lung adenocarcinoma cancer patients with MET amplication with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal
Drug: Crizotinib, bevacizumab
Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered
Other Name: XALKORI,AVASTIN




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months ]
  2. Response rate in patients with ALK translocation or ROS1 translocation or MET amplification [ Time Frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months ]
  3. Toxicity analysis: Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer [ Time Frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months ]
    Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of lung adenocarcinoma cancer
  • Availability of tumor tissue for ROS1, ALK, MET analyses
  • EGFR was wild type, positive for ROS1 translocation or ALK translocation or MET amplification
  • At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )
  • Patient didn't received any therapy for lung cancer before except surgery or radiotherapy, or the adjuvant chemotherapy had stopped for more than 12 months
  • Performance status 0-2 (ECOG)
  • Patient compliance to trial procedures
  • age ≥ 18 years
  • Written informed consent
  • Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl)
  • Adequate liver function (bilirubin <G2, transaminases no more than 3xULN/<5xULN in present of liver metastases).
  • Normal level of alkaline phosphatase and creatinine.
  • If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for ninety(90) days after end of treatment.

Exclusion Criteria:

  • Patients with EGFR mutation
  • No tumor tissue available or patient negative for ALK translocation or ROS1 translocation or MET amplification
  • Absence of any measurable lesion
  • Prior therapy with bevacizumab or ipilimumab
  • Symptomatic brain metastases
  • Previous radiotherapy on the target lesion(s). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
  • Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin
  • Pregnancy or lactating
  • Other serious illness or medical condition potentially interfering with the study
  • Significant known vascular disease
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment
  • Serious, non-healing wound, ulcer or bone fracture
  • Proteinuria at screening
  • Known hypersensitivity to any component of bevacizumab
  • History of hemoptysis within 3 months prior to study enrollment
  • Current, ongoing treatment with full-dose warfarin or its equivalent

Information from the National Library of Medicine

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): NCT02946359


Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: haitao tao, PhD    +861066937875    whatyouknow@126.com   
PLA general hospital Recruiting
BeiJing, Beijing, China, 100853
Contact: yi hu, M.D.       13718994934@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital

Responsible Party: yihu, Director of oncology department, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02946359     History of Changes
Other Study ID Numbers: CAMAR01
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Crizotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action