A Double Blind, Randomized, Phase II-III Maintenance Study of SR48692 Versus Placebo in Patients With Extensive Stage Small Cell Lung Cancer Following a First Line Chemotherapy With Cisplatin + Etoposide
- Pathological diagnosis: Histologically or cytologically proven SCLC.
- Disease stage: extensive stage
- Measurable disease by the RECIST criteria is required. Lesions that are present in
previously irradiated area are non-measurable unless they have appeared or progressed
since completion of the radiation.
- Radiotherapy, if applicable, must have been completed at least 4 weeks before
treatment under this protocol and the subject must have recovered from any acute
toxicities of radiation.
- Recovered from any surgical procedure(s).
- Calculated creatinine clearance > 55 ml/min using the Cockcroft-Gault formula: Cr Cl
in ml/min = (140-age) X (weight in kg) X (1.0 for men or 0.85 for women) / (72 X
serum Cr in mg/dl).
- Total bilirubin < two times the upper limit of the normal range at the institution
and SGOT/AST < two times the upper limit of normal unless liver metastases are
- ANC > 1.5 x 109/L and platelet count > 100 x 109/L.
- Age >18 years.
- Karnofsky Performance Status > 70% .
- Subjects with no prior malignancy, or subjects with cured malignancies other than
SCLC if: a) they are alive without disease recurrence for at least 5 years from the
date of pathological diagnosis, and b) clinical expectation of disease recurrence is
< 5% as documented in the medical record by the responsible physician, and c) they
have not received any platinum-based therapy. Subjects with basal cell carcinoma or
carcinoma in situ of the cervix may be eligible if adequately treated and clinical
expectation of disease recurrence is < 5% as documented in the medical record by the
- Infertile subjects or fertile subjects who use a medically acceptable contraceptive
throughout the treatment period and for 3 months following cessation of treatment.
Women of childbearing potential must have documentation of a negative, serum HCG
pregnancy test. Subjects must be made aware, before entering this trial, of the risk
in becoming pregnant or in fathering children.
- Signed written informed consent (approved by the Ethics Committee) obtained prior to
- Limited disease.
- Symptomatic brain metastases: a patient with brain and/or leptomeningeal metastases
on computer tomography (CT) or Magnetic Resonance Imaging (MRI) scan may be
included only if he/she is asymptomatic on neurologic exam and is not receiving
corticosteroid therapy to control symptoms.
- Concurrent active cancer, including cancer stable on adjuvant therapy.
- Prior immunotherapy, biological therapy or chemotherapy for SCLC.
- Radiotherapy: Prior radiation to non-symptomatic or non-life-threatening sites.Prior
radiation therapy to all potential indicator lesions. Prior radiation therapy to some
but not all indicator lesions is allowed.
- Class III or IV congestive heart failure according to the New York Heart Association
- History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3
antagonists) to be administered in conjunction with protocol-directed chemotherapy.
- Uncontrolled intercurrent illness.
- Lactating or pregnant women.
- Received any investigational drug within 30 days before beginning treatment with