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

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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