Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer

NCT01623102 | Unknown Phase 2

• 1 other identifier: WJP001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin chemotherapy is an effective treatment measures for EGFR mutation-negative NSCLC patients, but the prognosis remains poor. Chemotherapy combined with targeted monoclonal antibody treatment may be better treatment options in these patients. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether cisplatin and gemcitabine is more effective when given alone or with bevacizumab. This randomized trial studies how well giving cisplatin and gemcitabine alone or in combination with Bevacizumab (Avastin) works in treating patients with stage IIIB/IV non-squamous NSCLC without EGFR mutations.

Conditions

Lung Cancer

Keywords

Bevacizumab; gemcitabine; cisplatin; EGFR wild-type

Outcome Measures

Primary Outcomes (1)

• disease-free time to progression

  6 week

Secondary Outcomes (1)

• quality of life

  6 week

Study Arms (2)

Arm I: bevacizumab plus chemotherapy

EXPERIMENTAL

Patients in the experimental arm receive cisplatin and gemcitabine combination with Bevacizumab. GP chemotherapy (gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) plus bevacizumab (7.5 mg/kg IV on D1 of every 21-day cycle).

Drug: cisplatin and gemcitabine combination with Bevacizumab

Arm II: chemotherapy

ACTIVE COMPARATOR

Patients receive gemcitabine combined with cisplatin chemotherapy((gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) ) every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: Gemcitabine combined with cisplatin chemotherapy

Interventions

cisplatin and gemcitabine combination with Bevacizumab DRUG

Patients receive gemcitabine and cisplatin chemotherapy combined with Bevacizumab every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, cisplatin 75mg/m2 d1, Bevacizumab 7.5 mg / kg every 21 days.

Also known as: AVASTIN

Arm I: bevacizumab plus chemotherapy

Gemcitabine combined with cisplatin chemotherapy DRUG

Patients receive gemcitabine combined with cisplatin chemotherapy every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, + cisplatin 75mg/m2 d1.

Also known as: Gemzar

Arm II: chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation Negative.
• Stage IIIB/IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system
• Not received radiotherapy, chemotherapy or other biological treatment
• Measureable disease
• Life expectancy of \>= 12 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Absolute neutrophil count (ANC) \>= 2, 500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN in patients without liver or bone metastases; \< 5 x ULN in patients with liver or bone metastases
• Cockcroft-Gault calculated creatinine clearance of \>= 45 ml/min or creatinine =\< 1.5 x ULN
• Prothrombin time (PT) =\< 1.5 x ULN
• Partial thromboplastin time (PTT) =\< ULN
• Urine dipstick proteinuria \< 2+ \* Note: Patients discovered to have \>= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \< 1 g of protein in 24 hours

You may not qualify if:

• Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• Prior chemotherapy or treatment for metastatic non-small cell lung cancer
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy =\< 3 years prior to randomization; EXCEPTIONS: Non melanotic skin cancer or carcinoma-in-situ of the cervix
• History of myocardial infarction or other evidence of arterial thrombotic disease (angina)
• History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =\< 6 months prior to randomization
• Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
• History of bleeding diathesis or coagulopathy
• Inadequately controlled hypertension (systolic blood pressure of \> 150 mmHg or diastolic pressure \> 100 mmHg on anti-hypertensive medications)
• Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury =\< 28 days or core biopsy =\< 7 days prior to randomization
• History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess =\< 6 months prior to randomization
• History of hemoptysis \>= grade 2 (defined as bright red blood of at least 2.5 mL) =\< 3 months prior to randomization
• Pregnancy

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (2)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Bevacizumab; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• juan li, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

juan li, doctor

CONTACT

+8613880276636; dr.lijuan@gmail.com

rui shi, doctor

CONTACT

+8613880898008; shirui729@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: February 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

CN (2)