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

Learn more about:
Related Clinical Trial
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer Phase 1/2 Study of CISH Inactivated TILs in the Treatment of NSCLC Prognostic Value of Lung Cancer MicroAnatomy in 3D APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis Therapeutic ResistAnce and Clonal Evolution of ICIs Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma 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

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

Official Title

Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer

Brief Summary

      Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop
      growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy
      uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of
      non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus
      radiation therapy is more effective with or without AE-941 for non-small cell lung cancer.
      This randomized phase III trial is studying combination chemotherapy and radiation therapy
      given with AE-941 to see how well they work compared to combination chemotherapy and
      radiation therapy alone in treating patients with stage III non-small cell lung cancer that
      cannot be removed by surgery
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small
      cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or
      without AE-941 (Neovastat).

      II. Determine the progression-free survival, tumor response, tumor response duration, and
      metastasis-free survival of patients treated with these regimens.

      III. Determine the tolerability of this regimen in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to stage (IIIA vs IIIB), type of platinum-based induction
      chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and
      gender. Patients are randomized to 1 of 2 treatment arms.

      Arm I: Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10
      days of initiation of chemotherapy.

      Arm II: Patients receive oral placebo twice daily beginning on day 1 or within 10 days of
      initiation of chemotherapy.

      All patients receive induction chemotherapy with 1 of the following platinum-based regimens:
      cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71,
      and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57,
      64, 71, 78, and 85.

      All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms
      continues in the absence of unacceptable toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this
      study within 36 months.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall survival

Secondary Outcome

 Progression-free survival every 3 months

Condition

Adenocarcinoma of the Lung

Intervention

shark cartilage extract AE-941

Study Arms / Comparison Groups

 Arm I (shark cartilage extract AE-941)
Description:  Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10 days of initiation of chemotherapy.
All patients receive induction chemotherapy with 1 of the following platinum-based regimens: cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71, and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57, 64, 71, 78, and 85.
All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms continues in the absence of 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

Drug

Estimated Enrollment

756

Start Date

March 2000


Primary Completion Date

February 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed newly diagnosed, untreated, unresectable
             stage IIIA or stage IIIB non-small cell lung cancer

               -  Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma of the lung

               -  Mixed tumors allowed if non-small cell elements identified

               -  Contralateral supraclavicular and/or scalene lymph node involvement allowed

               -  No disease extending into the cervical region

          -  At least 1 bidimensionally or unidimensionally measurable lesion

          -  No pleural effusion unless cytologically negative or too small to safely aspirate

          -  Not scheduled for curative cancer surgery

          -  Performance status - ECOG 0-1

          -  Absolute neutrophil count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Hematocrit greater than 30%

          -  SGOT or SGPT less than 1.5 times upper limit of normal

          -  Bilirubin normal

          -  Creatinine less than 1.5 mg/dL

          -  Creatinine clearance greater than 60 mL/min

          -  No other major medical or psychiatric illness that would preclude study participation
             or consent

          -  No medical condition that interferes with oral medication intake and/or absorption
             (gastrectomy or major intestinal resection)

          -  No grade 2 or greater peripheral neuropathy unless secondary to mechanical etiology

          -  No hypersensitivity to fish products

          -  No more than 10% weight loss within past 3 months

          -  No other malignancy within past 3 years except inactive carcinoma in situ of the
             cervix or nonmelanoma skin cancer

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  At least 30 days since prior chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior major surgery

          -  At least 30 days since prior shark cartilage products

          -  No other concurrent investigational anticancer agents

          -  No other concurrent cartilage products

          -  No other concurrent investigational agents

          -  No concurrent amifostine or other radioprotectants

          -  No concurrent enrollment in other clinical trials
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Charles Lu, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00005838

Organization ID

NCI-2012-02725

Secondary IDs

ID99-303

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 Radiation Therapy Oncology Group

Study Sponsor

Charles Lu, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

January 2013