Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00290953
First received: February 10, 2006
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Lung Cancer
Pulmonary Neoplasms
Small Cell Lung Cancer
Drug: SR48692
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • - Overall survival (OS)

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

Enrollment: 432
Study Start Date: October 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290953

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

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00290953     History of Changes
Other Study ID Numbers: EFC3679
Study First Received: February 10, 2006
Last Updated: December 22, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by Sanofi:
Metastases

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014