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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Pulmonary Neoplasms, Small Cell Lung Cancer

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Trial Information

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


Inclusion Criteria:



- 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
present.

- 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
responsible physician.

- 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
study entry.

Exclusion Criteria:

- 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
Classification.

- 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
study drug.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

- Overall survival (OS)

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United Kingdom: National Health Service

Study ID:

EFC3679

NCT ID:

NCT00290953

Start Date:

October 2002

Completion Date:

March 2006

Related Keywords:

  • Lung Cancer
  • Pulmonary Neoplasms
  • Small Cell Lung Cancer
  • Metastases
  • Neoplasms
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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