Clinical trial NCT00042302 (phase 3, status: terminated)
Conditions: 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
Drugs: tariquidar + paclitaxel/carboplatin, placebo + paclitaxel/carboplatin
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H], [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          1. Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage
             IV, requiring first-line chemotherapy.

          2. Patients who have a WHO performance status of 1 or 0 and life expectancy of greater
             than 3 months.

          3. Patients who are 18 years of age or older and age of consent.

          4. Patients who are women of child-bearing potential must not be pregnant or lactating,
             must have a negative pregnancy test (serum or urine) at screening, and must be
             practicing an adequate method of birth control.

          5. Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or
             equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal
             or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times
             the upper limit of normal or, for patients with known liver metastases, less or equal
             to 5 times the upper limit of normal; and creatinine less or equal to 141 µmol/L (1.6
             mg/dL) or calculated creatinine clearance greater or equal to 60 mL/min prior to study
             treatment.

          6. Patients who are able to give written informed consent and comply with the protocol.

        Exclusion Criteria:

          1. Patients who are eligible for radiotherapy or surgery for curative intent.

          2. Patients who have had previous chemotherapy for NSCLC.

          3. Patients who have a WHO performance status greater than 1.

          4. Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor
             cells grow upon the walls of pre-existing alveoli, from WHO histological typing of
             lung tumors [1]).

          5. Patients who have previous or current primary malignancies at other sites within the
             last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the
             cervix and basal or squamous cell skin carcinoma.

          6. Patients who are a poor medical risk because of other nonmalignant systemic diseases
             or active uncontrolled infections.

          7. Patients who have symptomatic brain metastases.

          8. Patients who have peripheral neuropathy of CTC grade 2, 3, or 4.

          9. Patients who have other medical or surgical conditions that would contraindicate
             chemotherapy.

         10. Patients who have received experimental therapies within the last 4 weeks.

         11. Patients who have known hypervitaminosis or known sensitivity to ascorbic acid,
             vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or
             vitamin E.