Phase 3 N=186 Randomized Double-blind Treatment

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

Stage IIIA Non-small Cell Lung Cancer · Stage IIIB Non-small Cell Lung Cancer · Stage IV Non-small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00003869 ↗

Enrolled (actual)

186

Serious AEs

8.2%

Results posted

Dec 2010

Primary outcome: Primary: Overall Survival (OS) — 11.4; 10.5 Months — p=0.54

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: carboxyamidotriazole (Drug); placebo (Other); quality-of-life assessment (Procedure); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS)	11.4; 10.5	0.54
SECONDARY Participants With Severe Non-hematologic Adverse Events	38; 30	0.18
SECONDARY Time to Disease Progression (TTP)	2.8; 2.4	0.50
SECONDARY Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8	28; 32	0.04 sig
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	27; 33	0.18
SECONDARY Number of Patients With a Confirmed Tumor Responses Treated With CAI.	—	—

Summary

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. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

TRACK I: Histologically or cytologically confirmed NSCLC stage III or IV; disease must be stable or responding after standard chemotherapy (with or without TRT) for a minimum of 3 or a maximum of 6 months
TRACK I: Not required to have measurable or evaluable disease at study entry
TRACK I: Must have had one and only one prior chemotherapy regimen for NSCLC (radiosensitizers are allowed)
TRACK I: = = 1500/mm^3
TRACK I: PLT >= 100,000/mm^3
TRACK I: HgB >= 10.0 g/dL
TRACK I: Total bilirubin = = 1500/mm^3
TRACK II AT RANDOMIZATION: PLT >= 100,000/mm^3
TRACK II AT RANDOMIZATION: HgB >= 10.0 g/dL
TRACK II AT RANDOMIZATION: Total bilirubin =< 1.5 x UNL
TRACK II AT RANDOMIZATION: Alkaline phosphatase =< 3 x UNL
TRACK II AT RANDOMIZATION: AST =< 3 x UNL
TRACK II AT RANDOMIZATION: Creatinine =< 1.5 x UNL
TRACK II AT RANDOMIZATION: Expected survival of at least three months

Exclusion Criteria

TRACK I: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
TRACK I: Untreated brain metastases
TRACK I: Concomitant participation in a phase III lung cancer treatment trial
TRACK I: Planned concurrent chemotherapy, immunotherapy or radiotherapy
TRACK II AT RANDOMIZATION: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
TRACK II AT RANDOMIZATION: Untreated brain metastases
TRACK II AT RANDOMIZATION: Planned concurrent chemotherapy, immunotherapy, or radiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.