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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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ClinicalTrials.gov Identifier: NCT00005838
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 23, 2013
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 2, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE March 2000
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Overall survival [ Time Frame: From randomization until date of death or last follow-up, assessed up to 7 years ]
Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • Progression-free survival every 3 months [ Time Frame: From randomization until disease progression, assessed up to 7 years ]
    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.
  • Tumor response rate [ Time Frame: Up to 7 years ]
    Will be compared by chi-square test.
  • Tumor response duration [ Time Frame: From first observation of at least a partial response to detection of disease progression or death due to any cause, assessed up to 7 years ]
    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.
  • Metastasis-free survival [ Time Frame: From randomization until metastasis documented by imaging procedures, assessed up to 7 years ]
    Will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma of the Lung
  • Adenosquamous Cell Lung Cancer
  • Large Cell Lung Cancer
  • Squamous Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: shark cartilage extract AE-941
    Given orally
    Other Names:
    • AE-941
    • Neovastat
    • Neovastat/AE-941
  • Other: placebo
    Given orally
    Other Name: PLCB
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Drug: vinorelbine tartrate
    Given IV
    Other Names:
    • Eunades
    • navelbine ditartrate
    • NVB
    • VNB
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Radiation: radiation therapy
    Undergo radiotherapy
    Other Names:
    • irradiation
    • radiotherapy
    • therapy, radiation
Study Arms  ICMJE
  • Experimental: Arm I (shark cartilage extract AE-941)

    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.

    Interventions:
    • Drug: shark cartilage extract AE-941
    • Drug: cisplatin
    • Drug: vinorelbine tartrate
    • Drug: carboplatin
    • Drug: paclitaxel
    • Radiation: radiation therapy
  • Placebo Comparator: Arm II (placebo)

    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.

    Interventions:
    • Other: placebo
    • Drug: cisplatin
    • Drug: vinorelbine tartrate
    • Drug: carboplatin
    • Drug: paclitaxel
    • Radiation: radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
756
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00005838
Other Study ID Numbers  ICMJE NCI-2012-02725
ID99-303
U10CA045809 ( U.S. NIH Grant/Contract )
CDR0000067853 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE
  • Radiation Therapy Oncology Group
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Charles Lu M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP