Clinical trial NCT00735878 (phase 1/phase 2, status: terminated)
Conditions: non small cell lung cancer, 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: abt-751 and carboplatin
SMILES: COC1=CC=C(C=C1)S(=O)(=O)NC1=C(NC2=CC=C(O)C=C2)N=CC=C1
Reason stopped: 
    data from a similar did not show efficacy.
  
Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age.

          2. Pathologically or cytologically confirmed diagnosis of NSCLC .

          3. At least one measurable lesion (not amenable to resection) for Response Evaluation
             Criteria in Solid Tumors (RECIST) tumor assessments. Target lesions must not have been
             in the previous radiation port.

          4. Advanced stage of disease (IIIB with malignant pleural effusion or Stage IV) with no
             known curative treatment that has progressed despite therapy for recurrent/metastatic
             disease or prior therapy was discontinued due to intolerable toxicities. During the
             phase II portion of the study, previously untreated patients with IIIB with malignant
             pleural effusion or Stage IV NSCLC may be enrolled.

          5. For patients participating in the phase I part of the study, no alternative therapy is
             available that is expected to prolong overall or progression-free survival.
             Unacceptable toxicities during first- or second-line therapy or evidence for disease
             progression.

          6. Adequate hematologic, renal and hepatic function as follows:

               -  Hematologic: ANC (absolute neutrophil count) ≥ 1200/mm3; Platelets; ≥
                  100,000/mm3; hemoglobin: ≥ 8.5 g/dL;

               -  Renal function: serum creatinine ≤ 2.0 mg/dL; renal (CrCl > 50 ml/min by Jelliffe
                  or Cockcroft Gault Formula),

               -  Hepatic function: Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with liver
                  metastases); AST (aspartate aminotransferase) and ALT (alanine aminotransferase)
                  ≤ 2.5 X the upper limits of normal (ULN) (≤ 5 X ULN for patients with liver
                  metastases).

          7. Adequate performance status, Eastern Cooperative Oncology Group (ECOG) Performance
             Score of 0-1.

          8. Prior platinum (cisplatin, carboplatin or oxaliplatin) therapy is allowed.

          9. Patient or patient's legally acceptable representative has voluntarily signed and
             dated an informed consent form approved by an Institutional Review Board (IRB), prior
             to any study-specific procedures.

        Exclusion Criteria:

          1. Any other malignancy within 3 years except in situ carcinoma.

          2. Untreated central nervous system (CNS) metastasis.

          3. A greater than Grade 1 National Cancer Institute Common Toxicity Criteria (NCI CTC)
             neurology category findings at baseline.

          4. Concurrent anti-cancer therapy or radiotherapy.

          5. Concurrent therapy with colchicines.

          6. Prior therapy with ABT-751.

          7. Cytotoxic chemotherapy within 3 weeks of initiating investigational treatment.

          8. Any investigational therapy within 4 weeks.

          9. Female patients that are pregnant or breastfeeding.

         10. Patients of childbearing potential (male and female) that do not agree to use a
             contraceptive method deemed acceptable by the investigator while in the study and for
             up to three months following completion of therapy.

         11. Documented allergy or hypersensitivity to carboplatin or sulfa.

         12. Patient has received more than 2 prior chemotherapy regimens for advanced disease.
             Adjuvant chemotherapy administered more than 6 months prior to enrollment does not
             count towards this limit.

         13. Patient is classified as 3 or 4 by New York Heart Association (NYHA) Functional
             Classification, defined as:

             - Class 3: Patients with marked limitation of physical activity, comfortable at rest,
             but less than ordinary activity causes symptoms.

             - Class 4: Patients are unable to carry on any physical activity without symptoms and
             symptoms are present even at rest.

         14. Evidence of clinically significant medical condition(s) that compromises safety,
             compliance, or study conduct, and/or is considered by the investigator to be unable to
             tolerate the proposed treatment or procedures.