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


Phase 3
18 Years
N/A
Not Enrolling
Both
Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. To determine whether oral administration of the carboxyaminoimidazole (CAI) is more
effective than placebo in prolonging the overall survival in patients with non-small cell
lung cancer stage III or stage IV non-small cell lung cancer who have been stable or had
tumor regression following chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of oral CAI following chemotherapy. II. To
determine whether CAI prolongs time-to-disease progression relative to a placebo.

III. To evaluate whether a substantive effect in quality of life (QOL) can be detected
between the CAI and placebo groups using the FACT-L and the UNISCALE.

IV. To document the response rate to CAI in patients with measurable or evaluable disease.

TERTIARY OBJECTIVES:

I. To evaluate genotypes at GSH-related loci as predictors of overall survival.

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.


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: =< 6 weeks from last dose of chemotherapy or TRT

- TRACK I: ECOG PS 0, 1, or 2

- TRACK I: ANC >= 1500/mm^3

- TRACK I: PLT >= 100,000/mm^3

- TRACK I: HgB >= 10.0 g/dL

- TRACK I: Total bilirubin =< 1.5 x UNL

- TRACK I: Alkaline phosphatase =< 3 x UNL

- TRACK I: AST =< 3 x UNL

- TRACK I: Creatinine =< 1.5 x UNL

- TRACK I: Expected survival of at least three months

- TRACK II AT REGISTRATION: Histologically or cytologically confirmed NSCLC stage III
or IV

- TRACK II AT REGISTRATION: No prior chemotherapy for NSCLC

- TRACK II AT REGISTRATION: Expected survival of at least six months

- TRACK II AT REGISTRATION: Willingness to provide blood sample

- TRACK II AT RANDOMIZATION: STAB, PR, CR, REGR following 3-6 months of chemotherapy
with or without radiation therapy

- TRACK II AT RANDOMIZATION: Must have had one and only one prior chemotherapy regimen
for NSCLC (radiosensitizers are allowed)

- TRACK II AT RANDOMIZATION: =< 6 weeks from last dose of chemotherapy or TRT

- TRACK II AT RANDOMIZATION: ECOG PS 0, 1, or 2

- TRACK II AT RANDOMIZATION: ANC >= 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Edith Perez

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02898

NCT ID:

NCT00003869

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905