Clinical trial NCT00290953: Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lung Cancer
Pulmonary Neoplasms
Small Cell Lung Cancer
Keywords: Metastases
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: - Overall survival (OS)
Secondary outcomes:
measure: - Progression Free Survival (PFS)
measure: - Time to Progression (TTP)
measure: - Clinical Benefit assessed by Performance Status and body weight
measure: - Quality of Life using the LCSS and EuroQoL validated instruments
measure: - Toxicity and safety assessment using NCI CTC version 2.0
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-aventis adminsitrative office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: