Clinical trial NCT00040885 (phase 3, status: completed)
Conditions: anorexia, cachexia, fatigue, lung cancer
ICD codes: R63.0, F50.00, F50.01, F50.02, R64, R53.83, G93.3, R53.82, R53.0, T67.6XXS, T67.6XXA, T67.6XXD, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed unresectable non-small cell lung cancer that
             is considered incurable with other therapies

          -  Chemotherapy naive or previously treated disease

          -  Meets one of the following criteria:

               -  Age 65 and over with ECOG performance status of 0-2

               -  Under age 65 with ECOG performance status of 2

          -  No symptomatic or known untreated brain metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  See Disease Characteristics

          -  Adult

        Performance status:

          -  See Disease Characteristics

          -  ECOG 0-2

        Life expectancy:

          -  At least 3 months

        Hematopoietic:

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic:

          -  Bilirubin normal

          -  AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase less
             than ULN OR

          -  Alkaline phosphatase ≤ 4 times ULN if ALT less than ULN

          -  No ascites

        Renal:

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular:

          -  No prior or concurrent congestive heart failure

        Pulmonary:

          -  No prior tuberculosis or positive purified protein derivative skin test (tuberculin
             test)

        Other:

          -  No prior anaphylactic reaction to any taxane

          -  No known mechanical obstruction of the alimentary tract, malabsorption, or intractable
             vomiting (more than 5 episodes per week)

          -  No infection or chronic debilitating illness that would increase the risk of
             chemotherapy administration

          -  No grade 2 or greater peripheral neuropathy of any etiology

          -  No edema

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer

          -  Alert and mentally competent

          -  Able to complete questionnaires alone or with assistance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  See Disease Characteristics

          -  No prior docetaxel for metastatic non-small cell lung cancer

        Endocrine therapy:

          -  At least 1 month since prior adrenal steroids, androgens, progestational agents, or
             appetite stimulants

          -  No concurrent adrenal steroids, androgens, progestational agents, or appetite
             stimulants unless needed (e.g., steroids for CNS metastases)

          -  Concurrent inhaled, topical, or optical steroids allowed

          -  Concurrent short-term dexamethasone around days of chemotherapy administration allowed
             for protection against anaphylaxis and emesis

        Radiotherapy:

          -  More than 3 weeks since prior radiotherapy

          -  No prior radiotherapy to more than 25% of bone marrow

        Surgery:

          -  More than 3 weeks since prior major surgery

        Other:

          -  More than 3 weeks since other prior antineoplastic therapy