A Randomised Phase 3 Trial of Alimta (pemetrexed) and Carboplatin versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer.

• Conditions: Extensive stage Disease Small cell Lung cancer; MedDRA version: 8.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage

• Registration Number: EUCTR2006-001173-14-AT
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1820

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following
criteria:
[1] Histological or cytological diagnosis of ED-SCLC, including malignant pleural effusion (see Protocol Attachment JMHO.4 Staging of Small Cell Carcinoma of Lung).
[2] Performance status of 0 to 2 on the ECOG performance status schedule (Oken et al. 1982). (See Protocol Attachment JMHO.3)
[3] No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC.
[4] Prior radiation therapy allowed to <25% of the bone marrow. Patients who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible. Prior radiotherapy must be completed at least 2 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
[5] At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000). A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension and is =20 mm with conventional techniques or is =10 mm with spiral computed tomography (CT) scan (longest diameter to be recorded). Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements (see Protocol Attachment JMHO.5).
[6] Adequate organ function including the following:
• Adequate bone marrow reserve: absolute neutrophil (segmented and
bands) count (ANC) =1.5 x 109/L, platelets =100 x 109/L, and
hemoglobin =9 g/dL.
• Hepatic: bilirubin =1.5 times the upper limit of normal (ULN), alkaline
phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase
(AST) =3.0 x ULN (AP, AST, and ALT =5 x ULN is acceptable if liver
has tumor involvement).
• Renal: calculated creatinine clearance (CrCl) =45 mL/min based on the
standard Cockcroft and Gault formula (Cockcroft and Gault 1976). (See
Protocol Attachment JMHO.6)
[7] Estimated life expectancy of at least 12 weeks.
[8] For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding.
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
[9] Patient compliance and geographic proximity that allow adequate
follow up.
[10] Patient or his/her legal representative must sign an informed consent
document.
[11] Patients must be at least 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[13] Have previously participated in a study involving pemetrexed.
[14] Have a mixed histological diagnosis of SCLC and NSCLC.
[15] Have a serious concomitant systemic disorder that, in the opinion of
the investigator, would compromise the patient’s ability to adhere to the protocol.
[16] Have an active infection (=38.5ºC and/or receiving intravenous
antibiotic therapy).
[17] Have a serious cardiac condition, such as myocardial infarction within
6 months, angina, or heart disease as defined by the New York Heart Association Class III or IV (Protocol Attachment JMHO.8).
[18] Have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
[19] Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
[20] Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for =2 weeks and off of corticosteroids for =1 week.
[21] Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
[22] Significant weight loss (that is, =10%) over the 6 week period prior to study entry.
[23] Concurrent administration of any other antitumor therapy.
[24] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
[25] Inability or unwillingness to take folic acid or vitamin B12 supplementation.
[26] Inability to take corticosteroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified