A randomized phase 3 study of two doses of ALIMTA in patients with locally advanced or metastatic Non-Small Cell Lung Cancer who have failed a prior platinum-containing chemotherapy. - JMGX

• Register: EUCTR
• Last refreshed on: 15 April 2013
• Main ID: EUCTR2004-000815-25-AT
• Date of registration: 15/02/2005
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: A randomized phase 3 study of two doses of ALIMTA in patients with locally advanced or metastatic Non-Small Cell Lung Cancer who have failed a prior platinum-containing chemotherapy. - JMGX
• Scientific title: A randomized phase 3 study of two doses of ALIMTA in patients with locally advanced or metastatic Non-Small Cell Lung Cancer who have failed a prior platinum-containing chemotherapy. - JMGX
• Date of first enrolment: 22/03/2005
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000815-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
- Histologic or cytologic diagnosis of locally advanced or metastatic (Stage III or IV at entry) NSCLC that is not amenable to curative therapy.
- Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease.
Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence for incurable disease.
- No more than two prior systemic anticancer therapies will be allowed; no more than one prior therapy will be allowed for metastatic disease.
- Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the acute toxic effects of the regimen.
- Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- An ECOG performance status of 0 to 2.
- Estimated life expectancy of at least 8 weeks.
- Adequate organ function that includes the following indices:
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, alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 times upper limit of normal (AP, AST, and ALT £5 times the upper limit of normal is acceptable if liver has tumor involvement).
Renal: calculated creatinine clearance (CrCl) >45 mL/min using the standard Cockcroft and Gault formula
- 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:
- 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.
- Active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment (with the exception of in situ carcinoma of the cervix, adequately treated basal cell carcinoma, and early stage prostate cancer with Gleason grade £6).
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- Brain metastases. patients who are symptomatic for brain metastases must have a pretreatment computed tomography or magnetic resonance imaging (CT or MRI) of the brain. A patient with documented brain metastases at the time of study entry will be excluded from entering in the study. Patients with prior brain metastases may be considered if they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic.
- 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.
- Significant weight loss (that is, ³10% of body weight) over the 6 weeks before study entry.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or a corticosteroid.
- Have previously completed or withdrawn from this study or any other study investigating ALIMTA.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with locally advanced or metastatic Non-Smal Cell Lung Cancer who have failed a prior Platinum-containing chemotherapy.
MedDRA version: 7.0 Level: LLT Classification code 10059515

Intervention(s)

Trade Name: Alimta
Product Name: ALIMTA
Product Code: LY231514 disodium
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514 disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514 disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 900-

Primary Outcome(s)

Main Objective: The primary objective of this study is to compare overall survival time following treatment with ALIMTA 500 mg/m2 versus ALIMTA 900 mg/m2 in patients with locally advanced or metastatic (Stage III or IV) NSCLC who have failed a prior platinum-containing chemotherapy.

Primary end point(s): Overall survival time

Secondary Objective: The secondary objectives of the study include comparisons of the following outcomes between treatment regimens:
· progression-free survival
· tumor response rate (based on investigator-assessed best tumor response)
· incidence of laboratory and nonlaboratory adverse events by maximum Common Toxicity Criteria (CTC) toxicity grade and relationship to study drug
· incidence of treatment-emergent signs and symptoms.

Secondary ID(s)

H3E-MC-JMGX

N/A