Clinical trial NCT00003869 (phase 3, status: completed)
Conditions: stage iiia non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboxyamidotriazole
SMILES: NC(=O)C1=C(N)N(CC2=CC(Cl)=C(C(=O)C3=CC=C(Cl)C=C3)C(Cl)=C2)N=N1
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: =< 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