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Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: April 11, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003869
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether carboxyamidotriazole is more effective than no further treatment for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboxyamidotriazole
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control
Official Title: Phase III Randomized, Double-Blind Study of CAI and Placebo in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


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

Estimated Enrollment: 750
Study Start Date: April 1999
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the overall survival of patients with stage III or IV non-small cell lung cancer treated with oral carboxyamidotriazole (CAI) vs placebo.
  • Evaluate the safety and tolerability of oral CAI in these patients.
  • Compare the time to disease progression in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Determine the response rate of patients with measurable or evaluable disease treated with CAI.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to timing of first-line therapy (prior to registration vs after registration), disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral carboxyamidotriazole daily.
  • Arm II: Patients receive oral placebo daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then monthly during study.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 750 patients (375 per treatment arm) will be accrued for this study within 5 years.

  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 stage III or IV non-small cell lung cancer (NSCLC)
  • Received or plan to receive 1 and only 1 chemotherapy regimen with or without thoracic radiotherapy as first-line therapy for NSCLC
  • Disease must be stable or responding after prior or planned chemotherapy for 3-6 months
  • No untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months (patients who have received first-line therapy) OR
  • At least 6 months (patients who plan to receive first-line therapy)

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No other concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • Prior radiosensitizers allowed
  • No more than 6 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No more than 6 weeks since prior thoracic radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent participation in another phase III lung cancer treatment trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003869

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, California
California Cancer Center
Fresno, California, United States, 93720
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Health Plaza
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
Investigator: Mark Donald Hauge, MD Coborn Cancer Center
  More Information

Additional Information:
Publications:
Yang P, Mandrekar SJ, Hillman SH, Allen Ziegler KL, Sun Z, Wampfler JA, Cunningham JM, Sloan JA, Adjei AA, Perez E, Jett JR. Evaluation of glutathione metabolic genes on outcomes in advanced non-small cell lung cancer patients after initial treatment with platinum-based chemotherapy: an NCCTG-97-24-51 based study. J Thorac Oncol. 2009 Apr;4(4):479-85.
Johnson EA, Marks RS, Mandrekar SJ, Hillman SL, Hauge MD, Bauman MD, Wos EJ, Moore DF, Kugler JW, Windschitl HE, Graham DL, Bernath AM Jr, Fitch TR, Soori GS, Jett JR, Adjei AA, Perez EA; Additional participating institutions. Phase III randomized, double-blind study of maintenance CAI or placebo in patients with advanced non-small cell lung cancer (NSCLC) after completion of initial therapy (NCCTG 97-24-51). Lung Cancer. 2007 Nov 26; [Epub ahead of print]
Yang P, Mandrekar S, Hillman S, et al.: Glutathione pathway genes predict quality of life (QOL) in lung cancer patients: a NCCTG-97-24-51 based study. [Abstract] J Clin Oncol 25 (Suppl 18): A-18037, 686s, 2007 .
Johnson EA, Marks RS, Mandrekar S, et al.: A phase III randomized placebo controlled NCCTG trial of carboxyaminoimidazole (CAI) in patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7054, 634s, 2005.
Hillman SL, Sargent DJ, Bot, BM, et al.: Questionable value of attribution when interpreting adverse event data: a joint evaluation by North Central Cancer Treatment Group (NCCTG) and American College of Surgeons Oncology Group (ACOSOG). [Abstract] J Clin Oncol 25 (Suppl 18): A-6511, 324s, 2007.
Huschka MM, Mandrekar SJ, Schaefer PL, Jett JR, Sloan JA. A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials. Cancer. 2007 Jan 8;109(4):787-795 [Epub ahead of print]

Study ID Numbers: CDR0000067033, NCCTG-972451
Study First Received: November 1, 1999
Last Updated: April 11, 2009
ClinicalTrials.gov Identifier: NCT00003869     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Calcium, Dietary
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carboxyamido-triazole
Calcium Channel Blockers
Non-small Cell Lung Cancer
Cardiovascular Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Carboxyamido-triazole
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Carcinoma
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009