A Phase 3 Study of Pemetrexed Plus Best Supportive Care versus Best Supportive Care As Maintenance Therapy Immediately Following Induction Treatment For Advanced Non-Small Cell Lung Cancer

Conditions: on Small Cell Lung Cancer

Registration Number: EUCTR2004-002425-52-AT

Lead Sponsor: Eli Lilly and Company Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

Inclusion Criteria

[1]Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy. See Attachment JMEN.3, American Joint Committee on Cancer Staging Criteria (Fleming et al. 1997).
[2]Patients must have had one of the following induction therapies for treatment of Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin, or docetaxel plus cisplatin (see Section 5.5 for acceptable doses and schedules).
[3]Patients must have received only one chemotherapeutic doublet lasting precisely four cycles.
[4]Induction regimens must be based on 21-day cycles.
[5]Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized. Refer to Section 6.1.1 (and Attachment JMEN.5) for the definition of tumor response (RECIST; Therasse et al. 2000).
Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination (see Attachment JMEN.5).
[6]ECOG performance status (Oken et al. 1982) of 0 or 1 (see Attachment JMEN.4).
[7]At least 18 years of age.
[8]Adequate organ function, including the following:
·Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9 g/dL.
·Hepatic: bilirubin £1.5 times the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (ALP, AST, and ALT £5 ´ ULN are acceptable if the liver has tumor involvement).
·Renal: calculated creatinine clearance (CrCl) ³45 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
[9]Prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman 1987). Prior radiation to the whole pelvis is not allowed.
Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
[10]Signed informed consent document on file.
[11]Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
[12]Estimated life expectancy of at least 12 weeks.
[13]Patient compliance and geographic proximity that allow adequate follow up.
[14]Patient must receive on-study therapy no earlier than 21 days and no later than 42 days from their last cycle (Day 1) of induction therapy.

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

[15]With the exception of those chemotherapies listed as Inclusion criterion [2], patients will be excluded if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.
[16]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.
[17]Inability to comply with protocol or study procedures.
[18]A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
[19]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 (see Attachment JMEN.6).
[20]Central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy). A screening computed tomography (CT) or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.
[21]Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
[22]Concurrent administration of any other antitumor therapy.
[23]Inability to interrupt aspirin or other nonsteroidal anti?inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long?acting agents, such as piroxicam).
[24]Inability or unwillingness to take folic acid or vitamin B12 supplementation.
[25]Inability or unwillingness to take corticosteroids.
[26]Received an induction chemotherapy regimen that was not based on a 21-day cycle.
[27]Pregnant or breast feeding.
[28]Have a prior malignancy other than NSCLC, 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare maintenance therapy with pemetrexed plus BSC versus placebo plus BSC, in terms of the overall survival time (OS) in patients with Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC who have not progressed during four cycles of platinum?based induction chemotherapy.;Secondary Objective: The secondary objectives of the study are to compare the following between the randomized treatment arms:<br>·time-to-event efficacy endpoints:<br>-progression-free survival time (PFS)<br>-time to objective progressive disease (TPD)<br>-time to worsening of symptoms (TWS)<br>·objective tumor response rate<br>·adverse events<br>·changes in individual symptom scores and quality of life using the Lung Cancer Symptom Scale (LCSS) <br>;Primary end point(s): Overall Survival

Secondary Outcome Measures

Name	Time	Method

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