Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003007-39-BE
• Date of registration: 23/04/2007
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company limited
• Public title: Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - N/A
• Scientific title: Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - N/A
• Date of first enrolment: 25/04/2007
• Target sample size: 61
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003007-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: no Other:

Countries of recruitment

Belgium, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
Patients may be included in the study only if they meet all of the following criteria:
[1] Histologic and/or [cytologic] diagnosis of LS-SCLC, without cytological proven malignant pleural effusion and confined to one hemithorax as defined by the IASLC 1989 criteria (
[2] Performance status of 0 to 1 on the ECOG performance status schedule
[3] no prior chemo- and/ or prior thoracic radiotherapy
[4] Measurable disease defined by:
• At least one unidimensionally measurable lesion meeting RECIST criteria
[5] adequate organ function including the following:
Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x10e9/L, platelets =100 x10e9/L, and hemoglobin =9 g/dL.
Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < or = 3.0 x ULN.
Renal: calculated creatinine clearance (CrCl) =60mL/min based on the standard Cockroft and Gault formula
[6] adequate pulmonary function as defined as a Forced Expiratory Volume in 1 sec (FEV1) > 30% predicted normal value and diffusion capacity (DLCO) > 40% predicted normal value.
[7] unlikely to be at excessive risk for radiation pneumonitis as defined by a V20 of =36% and able to drain 3rd space fluids
[8] Patient compliance and geographic proximity that allow adequate follow-up.
[9] Patients must sign an informed consent document.
[10] Patients must be at least 18 years of age.
[11] For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating.
For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.

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] 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] Completion or withdrawal from this study or any other study investigating pemetrexed.
[14] Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia.
[15] Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
[16] Prior radiotherapy to the lower neck or abdominal region.
[17] Discovery of a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
[18] Significant weight loss (that is, U>10%) over the previous 6 weeks before study entry.
[19] Concurrent administration of any other antitumour therapy.
[20] 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).
[21] Inability or unwillingness to take folic acid or vitamin B12 supplementation.
[22] Inability to take corticosteroids.
[23] Inability to comply with protocol or study procedures.



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

Health Condition(s) or Problem(s) studied

Limited Stage Small Cell Lung Cancer
MedDRA version: 8.1 Level: LLT Classification code 10041069 Term: Small cell lung cancer limited stage

Intervention(s)

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

Primary Outcome(s)

Main Objective: The primary objective of the phase I part of this study is to determine the recommended Phase 2 dose of pemetrexed, cisplatin, and involved-field radiotherapy in the treatment of patients with LS-SCLC.

The primary objective of the phase II part of this study is to further delineate the activity of this regimen at the recommended dose in terms of overall response rate

Primary end point(s): The primary endpoint for Phase I is the determination of the recommended Phase II dose of pemetrexed, cisplatin, and involved-field radiotherapy for subsequent evaluation in the treatment of patients with LS-SCLC.

The primary endpoint for Phase II is to further delineate the activity of this regimen at the recommended dose in terms of overall response rate.

Secondary Objective: Secondary objectives:
• to determine the maximum tolerated dose of pemetrexed, cisplatin and involved-field radiotherapy.
•to determine the quantitative and qualitative dose-limiting toxicities of pemetrexed in combination with cisplatin and curative thoracic radiation therapy in this patient population.
• further characterization of acute and late toxicities
• to document objective best overall response
Phase II: Secondary objectives of the study include the following:
• further characterization of acute and late toxicities,
• to determine complete response rate
• to assess time-to-event:
- Time to progressive disease
- Duration of Response
- Overall Survival.

Secondary ID(s)

H3E-EW-S107

2006-003007-39-NL