Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Lung Cancer
Interventions:	Drug: Carboxyamidotriazole Other: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 1999 and January 2004, 194 patients were accrued to this study. This trial was closed to accrual prior to meeting the protocol projected 360 randomized patients due to slow accrual.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
186 patients were randomized to either arm

Reporting Groups

	Description
Carboxyamidotriazole	250 mg carboxyamidotriazole administered daily
Placebo	250 mg placebo administered daily

Participant Flow: Overall Study

	Carboxyamidotriazole	Placebo
STARTED	94	92
COMPLETED	53	80
NOT COMPLETED	41	12
Adverse Event	14	3
Withdrawal by Subject	21	3
Death	1	2
Alternative treatmnt, medical problems	5	4

Baseline Characteristics

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Reporting Groups

	Description
Carboxyamidotriazole	250 mg carboxyamidotriazole administered daily
Placebo	250 mg placebo administered daily

Baseline Measures

	Carboxyamidotriazole	Placebo	Total
Number of Participants [units: participants]	94	92	186
Age, Customized [units: participants]
<= 65 years	37	50	87
> 65 years	57	42	99
Gender [units: participants]
Female	42	37	79
Male	52	55	107
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	1	1	2
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	91	89	180
More than one race	0	0	0
Unknown or Not Reported	2	1	3
Histology [units: participants]
Bronchoalveolar/large cell	6	13	19
NOS (not otherwise specified) NSCLC/not avaliable	16	11	27
Adenocarcinoma	51	55	106
Squamous	21	13	34
Eastern Cooperative Oncology Group Performance Score ^[1] [units: Participants]
0 - Fully Active	37	38	75
1 - Ambulatory, restricted strenuous activity	47	48	95
2 - Ambulatory, unable to perform work activities	10	6	16
Prior Response to Chemotherapy [units: participants]
Complete	5	4	9
Partial	38	45	83
Regression	9	8	17
Stable	42	35	77
Smoking Status [units: participants]
Never	11	10	21
Former (quit >= 6 months)	54	57	111
Current	20	15	35
Not Reported	9	10	19
TNM Stage ^[2] [units: participants]
IIIA/IIIB	22	19	41
IV	72	73	145

[1]	Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
[2]	American Joint Committee on Cancer, Cancer Staging Manual http://www.cancerstaging.org/products/pasteditions.html

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: up to 5 years ]

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2. Secondary:

Participants With Severe Non-hematologic Adverse Events [ Time Frame: every cycle during treatment ]

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3. Secondary:

Time to Disease Progression (TTP) [ Time Frame: up to 5 years ]

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4. Secondary:

Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8 [ Time Frame: Baseline to week 8 ]

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5. Secondary:

Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8 [ Time Frame: Baseline to week 8 ]

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6. Secondary:

Number of Patients With a Confirmed Tumor Responses Treated With CAI. [ Time Frame: During Treatment (up to 5 years) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Edith A. Perez
Organization: Mayo Clinic
e-mail: perez.edith@mayo.edu

Publications of Results:

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, Allen K, Jett J, Perez E, Adjei A. 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, Hillman S, Mailliard J, Dentchev T, Reuter N, Jett J, Perez EA. 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.

Other Publications:

Hillman SL, Sargent DJ, Bot, BM, DeMatteo RP, Perez EA, Ballmann KV, Mandrekar SJ. 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]

Hillman SL, Mandrekar SJ, Bot B, Dematteo RP, Perez EA, Ballman KV, Nelson H, Buckner JC, Sargent DJ. Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation. J Clin Oncol. 2010 May 17; [Epub ahead of print]

Responsible Party:	Edith A. Perez, M.D., North Central Cancer Treatment Group
ClinicalTrials.gov Identifier:	NCT00003869 History of Changes
Other Study ID Numbers:	CDR0000067033, U10CA025224, 972451, 1795-98, NCCTG-97-24-51
Study First Received:	November 1, 1999
Results First Received:	November 24, 2010
Last Updated:	January 4, 2011
Health Authority:	United States: Federal Government