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

Completed · Phase 3 · Has a placebo group

Conditions studied: Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT00003869
Run by: National Cancer Institute (NCI)
People needed: 186
Starts: 1999-04-01
Expected to finish: 2008-05-01
Last updated by the study team: 2014-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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