Clinical Trial: 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

This study is currently recruiting patients.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Center for Complementary and Alternative Medicine (NCCAM)
Radiation Therapy Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition Treatment or Intervention Phase
Squamous Cell Lung Cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
 Drug: AE-941
 Drug: carboplatin
 Drug: cisplatin
 Drug: paclitaxel
 Drug: vinorelbine
 Procedure: alternative product therapy
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemotherapy
 Procedure: complementary and alternative therapy
 Procedure: growth factor antagonist therapy
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Induction Platinum-Based Chemotherapy and Radiotherapy With or Without AE-941 (Neovastat) in Patients With Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%

Hepatic:

  • SGOT or SGPT less than 1.5 times upper limit of normal
  • Bilirubin normal

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 30 days since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • Recovered from prior major surgery

Other:


Location and Contact Information


Connecticut
      Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford,  Connecticut,  06102-5037,  United States; Recruiting
Robert D. Siegel, MD  860-249-6291    rsiegel@harthosp.org 

      Whittingham Cancer Center at Norwalk Hospital, Norwalk,  Connecticut,  06856,  United States; Recruiting
Richard C. Frank, MD  203-845-2132 

Florida
      Florida Radiation Oncology Group, Jacksonville,  Florida,  32207,  United States; Recruiting
Douglas W. Johnson, MD  904-202-7020    djohn005@bmcjax.com 

      M.D. Anderson Cancer Center - Orlando, Orlando,  Florida,  32806-2134,  United States; Recruiting
Jennifer Tseng, MD  321-841-1882    jtseng@mdanderson.org 

      Tallahassee Memorial Hospital, Tallahassee,  Florida,  32308,  United States; Recruiting
Timothy W. Bolek, MD  850-431-5255 

      University of Miami Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States; Recruiting
Arnold Markoe, MD, ScD  305-243-4319    amarkoe@med.miami.edu 

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

      Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States; Recruiting
Robert E. Share, MD  708-915-6620    Rshare@ingalls.org 

Indiana
      Bloomington Hospital, Bloomington,  Indiana,  47402,  United States; Recruiting
David Y. Lee, MD  812-353-2800    dlee@bloomhealth.org 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

Kentucky
      Cancer Center at Lexington Clinic, Lexington,  Kentucky,  40504,  United States; Recruiting
Douglas David Martin, MD  859-258-6505    dmart@lexclin.com 

Louisiana
      Christus St. Frances Cabrini Center for Cancer Care, Alexandria,  Louisiana,  71301,  United States; Recruiting
Al-Halawani Hafez, MD  318-561-4186    halhalawani@pol.net 

Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Michael C. Perry, MD  573-882-4979    perrym@health.missouri.edu 

Nebraska
      Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha,  Nebraska,  68114-4199,  United States; Recruiting
James A. Wheeler, MD  402-354-8250    jwheele@nmhs.org 

North Dakota
      Trinity Cancer Care Center, Minot,  North Dakota,  58701,  United States; Recruiting
Kevin Basil Collins, MD  701-857-3553    kevin.collins@trinityhealth.org 

Ohio
      Akron City Hospital at Summa Health System, Akron,  Ohio,  44304,  United States; Recruiting
William F. Demas, MD  330-374-4221    demasw@summa-health.org 

South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-6812 

Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77230-1402,  United States; Recruiting
Charles Lu, MD  713-792-6363    clu@mdanderson.org 

Utah
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States; Recruiting
William T. Sause, MD  801-408-2058    ldwsause@ihc.com 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Tarit Kumar Banerjee, MD, FACP  715-387-5134 

Canada, Alberta
      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Collum J. Smith, MD  403-670-1709    colums@cancerboard.ab.ca 

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Andrew Makymiuk, MD  204-787-2882    andrew.makymiuk@cancercare.mb.ca 

Canada, Nova Scotia
      Cape Breton Cancer Centre, Sydney,  Nova Scotia,  B1P 1P3,  Canada; Recruiting
Ron MacCormick, MD  902-567-8080    maccormickr@cbdha.nshealth.ca 

Canada, Ontario
      Cancer Centre of Southeastern Ontario, Kingston,  Ontario,  K7L 5P9,  Canada; Recruiting
Richard W. Gregg, MD  613-544-2630    richard.gregg@krcc.on.ca 

      Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay,  Ontario,  P7B 6V4,  Canada; Recruiting
Dimitrios Vergidis, MD  807-684-7200    vergidid@tbh.net 

Canada, Quebec
      Centre Hospitalier Regional de Rimouski, Rimouski,  Quebec,  G5L 5T1,  Canada; Recruiting
Joffre-Claude Allard, MD  418-723-7851    jallard@ssss.gouv.qc.ca 

      CHUS-Hopital Fleurimont, Sherbrooke,  Quebec,  J1H 5N4,  Canada; Recruiting
Jean Dufresne, MD  819-346-1110    jean.dufresne@usherbrooke.ca 

      Complexe Hospitalier de la Sagamie, Chicoutimi,  Quebec,  G7H 5H6,  Canada; Recruiting
Herve Simard, MD  418-541-1000 ext 2092 

      Hopital Charles Lemoyne, Greenfield Park,  Quebec,  J4V 2H1,  Canada; Recruiting
Pierre Desjardins, MD  450-466-5000 

      Jewish General Hospital - Montreal, Montreal,  Quebec,  H3T 1E2,  Canada; Recruiting
Gerald Batist, MD  514-340-8248    gbatist@onc.jgh.mcgill.ca 

      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting
Vera Hirsh, MD, FRCPC  514-842-1231 ext. 35997    vera.hirsh@nuhc.mcgill.ca 

Puerto Rico
      MBCCOP - San Juan, San Juan,  00921-3201,  Puerto Rico; Recruiting
Luis Baez-Diaz, MD  787-641-3693    sjccop@prtc.net 

Study chairs or principal investigators

Charles Lu, MD,  Study Chair,  M.D. Anderson Cancer Center   
Roy Herbst, MD, PhD,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067853; MDA-ID-99303; NCCAM; NCI-T99-0046; NCT00005838; RTOG-0270
Record last reviewed:  March 2005
Last Updated:  April 4, 2005
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005838
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005