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 - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	National Cancer Institute (NCI) National Center for Complementary and Alternative Medicine (NCCAM) Radiation Therapy Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005838

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	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: shark cartilage extract AE-941 Drug: vinorelbine ditartrate Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Cisplatin Paclitaxel Carboplatin Vinorelbine Vinorelbine tartrate Shark cartilage extract AE 941 Benefin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival every 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival every 3 months [ Designated as safety issue: No ]

Study Start Date:	March 2000
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005838

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Locations

United States, Connecticut
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
Florida Radiation Oncology Group at Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806-2134
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Regional Cancer Institute at Bloomington Hospital
Bloomington, Indiana, United States, 47403
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Lexington Clinic Cancer Center
Lexington, Kentucky, United States, 40504
United States, Louisiana
Christus St. Frances Cabrini Center for Cancer Care
Alexandria, Louisiana, United States, 71301
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309-2090
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Canada, Quebec
Centre de Sante et de Services Sociaux de Chicoutimi
Chicoutimi, Quebec, Canada, G7H 5H6
Centre Hospitalier Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00921-3201

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

National Center for Complementary and Alternative Medicine (NCCAM)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Charles Lu, MD, SM	M.D. Anderson Cancer Center
Investigator:	Roy S. Herbst, MD, PhD	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

Lu C, Lee JJ, Komaki R, et al.: A phase III study of AE-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303). [Abstract] J Clin Oncol 25 (Suppl 18): A-7527, 391s, 2007.

Lu C, Komaki R, Herbst RS, et al.: A phase III study of AE-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): an interim report of toxicity and response. [Abstract] J Clin Oncol 23 (Suppl 16): A-7144, 656s, 2005.

Study ID Numbers:	CDR0000067853, MDA-ID-99303, NCCAM, NCI-T99-0046, RTOG-0270
Study First Received:	June 2, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005838 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators

Carboplatin
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009