| Inclusion Criteria: | 1) Male or female patients with an age >/= 18 years
2) Histologically or cytologically proven SCLC: Part A: Unresponsive to curative surgery, radiotherapy, ≤ 3 lines of conventional chemotherapy or for which no conventional therapy exists. (Measurable or evaluable disease is desirable, but not required) Additionally, patients with histologically or cytologically proven solid tumors unresponsive to curative surgery, radiotherapy, conventional chemotherapy or for which no conventional therapy exists are also eligible. (Measurable or evaluable disease is desirable, but not required).
3) Performance Status </=2
4) Adequate bone marrow function without support (cytokines and/or Epoetin Alpha) within 5 days prior to dosing: Absolute neutrophil count (ANC) >/=1,500/mm^3, platelet count >/= 100,000/mm^3, Hgb >/= 9.0 g/dL.
5) Adequate liver function: total bilirubin level </= 2.0 mg/dL, ALT and AST </=2.0 x institutional upper limit of normal in the absence of liver metastasis, or </=4.0 x institutional upper limit of normal in the presence of liver metastasis.
6) Adequate renal function: a calculated creatinine clearance (using the Cockroft and Gault equation) of >/=60 mL/min.
7) Prior Chemotherapy: Part A: At least 3 weeks since last dose of prior chemotherapy or cancer surgery (6 weeks for nitrosourea or mitomycin C). Part B: At least 60 days since last dose of first-line chemotherapy for SCLC
8) No concurrent antineoplastic agents or hormonal anti-cancer therapy.
9) If brain metastases present, need to be clinically stable without current use of corticosteroids and patient at least 3 weeks post brain radiation. Patients with brain metastases present must have evaluable disease outside the CNS.
10) Disease-free from prior malignancies >/=5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
11) Normal cardiac function with no history of unstable coronary artery disease.
12) Female patients (if of child-bearing potential and sexually active) and male patients (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control prior to study entry and for the duration of the study. Medically acceptable methods of contraception that may be used by the patient and/or his/her partner include abstinence, birth control pills or patches, diaphragm and spermicide, IUD, condom and vaginal spermicide, surgical sterilization, post-menopausal, vasectomy, and progestin implant or injection.
13) Written informed consent. |