Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide (SESAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290953
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : December 23, 2008
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Brief Summary:

To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide.

Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm.

Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.

Condition or disease Intervention/treatment Phase
Lung Cancer Pulmonary Neoplasms Small Cell Lung Cancer Drug: SR48692 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2002
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. - Overall survival (OS)

Secondary Outcome Measures :
  1. - Progression Free Survival (PFS)
  2. - Time to Progression (TTP)
  3. - Clinical Benefit assessed by Performance Status and body weight
  4. - Quality of Life using the LCSS and EuroQoL validated instruments
  5. - Toxicity and safety assessment using NCI CTC version 2.0

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290953

Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-aventis adminsitrative office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Barcelona, Spain
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00290953     History of Changes
Other Study ID Numbers: EFC3679
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action