Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
Condition: Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboxyamidotriazole; placebo; quality-of-life assessment; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Ancillary studies; Correlative studies
Intervention MeSH terms: Carboxyamido-triazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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: =< 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