Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

April 11, 2009

Start Date ^ICMJE

April 1999

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003869 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Official Title ^ICMJE

Phase III Randomized, Double-Blind Study of CAI and Placebo in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: carboxyamidotriazole

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Estimated Enrollment ^ICMJE

750

Completion Date

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00003869

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067033, NCCTG-972451

Study Sponsor ^ICMJE

North Central Cancer Treatment Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Edith A. Perez, MD	Mayo Clinic
Investigator:	Mark Donald Hauge, MD	Coborn Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2008

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