S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

Learn more about:
Related Clinical Trial
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Icotinib for Completed Resected IB NSCLC With EGFR Mutation Circulating Tumor DNA in Patients at High Risk for Lung Cancer Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery QUILT-3.017: Study of NEO-201 in Solid Tumors Photodynamic Therapy in Treating Patients With Lung Cancer Vaccine Treatment for Advanced Non-Small Cell Lung Cancer S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC The Tracking Molecular Evolution for NSCLC (T-MENC) Study Phase 1a/1b Study of TPST-1495 Alone and With Pembrolizumab in Subjects With Solid Tumors An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Lung Cancer Mutation Consortium Protocol The Detection of EGFR Mutations in Liquid Based Cytology Samples NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03) Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR Telomere Biology in Early Adenocarcinoma of the Lung

Brief Title

S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer

Official Title

A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Brief Summary

      Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Cetuximab may also stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop
      the growth of tumor cells by blocking blood flow to the tumor. 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. Giving cetuximab together with
      paclitaxel, carboplatin, and bevacizumab may kill more tumor cells. This phase II trial is
      studying how well giving cetuximab together with paclitaxel, carboplatin, and bevacizumab
      works in treating patients with advanced non-small cell lung cancer
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the frequency and severity of hemorrhage toxicities in patients with advanced
      non-small cell lung cancer treated with the combination of carboplatin, paclitaxel, cetuximab
      and bevacizumab followed by therapy with cetuximab and bevacizumab.

      SECONDARY OBJECTIVES:

      I. To evaluate progression-free and overall survival, response rate (confirmed plus
      unconfirmed, complete plus partial), and frequency and severity of non-hemorrhage toxicities
      in this group of patients treated with this regimen.

      II. To perform molecular correlative studies on patient tissue to investigate in an
      exploratory manner potential predictors of efficacy.

      OUTLINE: This is a multicenter study.

      INDUCTION THERAPY: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and
      paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90
      minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of
      disease progression or unacceptable toxicity.

      MAINTENANCE THERAPY: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and
      bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year and then
      every 6 months for up to 3 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.

Secondary Outcome

 Progression-Free Survival

Condition

Adenocarcinoma of the Lung

Intervention

cetuximab

Study Arms / Comparison Groups

 Treatment (cetuximab, paclitaxel, bevacizumab)
Description:  INDUCTION THERAPY: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

110

Start Date

August 2006

Completion Date

October 2010

Primary Completion Date

October 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically proven newly diagnosed selected
             stage IIIB (T4 lesion due to malignant pleural effusion) or stage IV, advanced primary
             non-small cell lung cancer (adenocarcinoma, large cell carcinoma, or unspecified) or
             recurrent disease after previous surgery and/or irradiation; patients with tumors
             having squamous cell components > 50% are not eligible

          -  Patients with known brain metastases are not eligible; all patients must have a
             pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 42 days
             prior to registration

          -  Patients may have measurable or non-measurable disease documented by CT, MRI, X-ray or
             physical exam; measurable disease must be assessed within 28 days prior to
             registration; pleural effusions, ascites and laboratory parameters are not acceptable
             as the only evidence of disease; non-measurable disease must be assessed within 42
             days prior to registration; all disease must be assessed and documented on the
             Baseline Tumor Assessment Form (Form #848)

          -  Patients must not have received any prior systemic chemotherapy or biologic therapy
             for non-small cell lung cancer; patients must not have received any adjuvant therapy
             for non-small cell lung cancer

          -  Prior radiation is permitted; however, at least three weeks must have elapsed since
             the completion of prior radiation therapy and patients must have recovered from all
             associated toxicities at time of registration; measurable or non-measurable disease
             must be outside the previous radiation field or a new lesion must be present

          -  At least four weeks must have elapsed since surgery (thoracic or other major
             surgeries) and patients must have recovered from all associated toxicities at the time
             of registration; measurable disease must be present outside the area of surgical
             resection; there must be no anticipation of need for major surgical procedures during
             protocol treatment

          -  Patients must not have received prior cetuximab, ZD1839, erlotinib or other
             investigational agents that target the EGFR pathway; patients must not have received
             prior VEGF-related agents; patients must not have received prior chimerized or murine
             monoclonal antibody therapy or have documented presence of human anti-mouse antibodies
             (HAMA)

          -  ANC >= 1,500/mcl

          -  Platelet count >= 100,000/mcl

          -  Hemoglobin >= 9 mg/dl

          -  Patients must have a serum creatinine =< institutional upper limit of normal (IULN)
             AND calculated or measured creatinine clearance >= 50 cc/min using the Cockroft-Gault
             Formula

          -  Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC)
             ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must
             be < 1,000 mg for patient enrollment

          -  Serum bilirubin =< 2 x IULN

          -  Either SGOT or SGPT =< 2 x IULN (if both SGOT and SGPT are done, both must be =< 2 x
             IULN)

          -  International Normalized Ratio (INR) =< 1.5; patients must not be taking full-dose
             anticoagulation therapy; patients may be enrolled initially if they are on low-dose
             warfarin (i.e., 1 mg daily)

          -  All patients must have a Zubrod performance status of 0 - 1

          -  Correlative science studies: institutions must have received IRB approval of S9925
             (the Lung Cancer Specimen Repository); patients must be offered participation in
             S9925; with the patient's consent, blood, plasma and tissue will be submitted for
             testing via S9925; patients must be registered separately to S9925 in order for
             institutions to receive credit for specimen submissions

          -  Patients must not have had hemoptysis >= 1/2 teaspoon within 3 months prior to
             registration

          -  Patients must not have >= grade 2 symptomatic neuropathy-sensory (National Cancer
             Institute [NCI] Common Terminology Criteria Version 3.0)

          -  Patients must not have documented evidence of acute hepatitis or have an active or
             uncontrolled infection

          -  Patients must not have the following: history (within past 6 months) of CVA,
             myocardial infarction or unstable angina; uncontrolled hypertension; New York Heart
             Association grade 2 or greater congestive heart failure; serious cardiac arrhythmia
             requiring medication; or clinically significant peripheral vascular disease

          -  Patients must not have had an open biopsy or significant traumatic injury within 28
             days prior to registration; patients must not have had a core biopsy within 7 days
             prior to registration

          -  Patients must not have serious or non-healing wound, ulcer or bone fracture

          -  Patients must not have history of abdominal fistula, gastrointestinal perforation or
             intraabdominal abscess within 28 days prior to registration

          -  Patients must have no known hypersensitivity of Chinese hamster ovary cell products or
             other recombinant human antibodies

          -  Patients must not have evidence of bleeding diathesis or coagulopathy

          -  Patients must be willing to provide prior smoking history as required on the S0536
             Prestudy Form (Form #54655)

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for 5 years

          -  Pregnant or nursing women are not eligible for this trial; women/men of reproductive
             potential must not participate unless they have agreed to use an effective
             contraceptive method during protocol treatment and for at least 6 months following
             completion of bevacizumab treatment

          -  Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and ID number
             must be provided to the Data Operations Center in Seattle in order to ensure that the
             current (within 365 days) date of institutional review board approval for this study
             has been entered into the data base
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Edward Kim, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00368992

Organization ID

NCI-2012-02903

Secondary IDs

S0536

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Edward Kim, Principal Investigator, Southwest Oncology Group


Verification Date

February 2013