A Randomized (Phase II), Double-blind, Multicenter Phase I/II trial of Pemetrexed, Carboplatin plus or minus Sorafenib in the First-line Treatment of Patients with Stage IIIb or IV Non-Small Cell Lung Cancer - PECASO

Active, not recruiting

• Conditions: Treatment of metastacic non small cell lung cancer (NSCLC) stage IIIB / IV; MedDRA version: 9.1Level: PTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2006-005970-26-DE
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-11
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Histologically or cytologically confirmed NSCLC
•Locally advanced (stage IIIB with malignant pleural or pericardial effusion)
or metastatic (stage IV) NSCLC
•No prior systemic chemotherapy
•Prior local radiotherapy is allowed if it is completed at least 3 weeks prior
to the first dose of study medication; also concomitant palliative
radiotherapy to an existing bone lesion for pain control is allowed
•Prior surgery is allowed if it is performed at least 4 weeks prior to the first
dose of study medication and patient should be fully recovered.
•Must have measurable disease with at least one lesion with a longest
diameter measured as = 2 cm with conventional techniques or as = 1 cm
with spiral CT
•Age =18 years old
•ECOG performance score (PS) 0-1
•Life expectancy of at least 12 weeks
•Adequate bone marrow, renal and hepatic function
ohemoglobin = 9.0 g/dl
oabsolute neutrophil count =1,500/mm3
oplatelet count = 100,000/mm3
ototal bilirubin = 1.5 times the upper limit of normal
oALT and AST = 2.5 times the upper limit of normal (= 5 x upper limit of
normal for patients with liver involvement)
oINR = 1.5 and aPTT within normal limits
oserum creatinine = 1.5 the upper limit of normal
•Patients with creatinine clearance = 45 mL/min
•Not pregnant or nursing patients
•Women of childbearing potential must have a negative serum pregnancy
test performed within 7 days prior to the start of treatment
•Women of childbearing potential and men must agree to use adequate
contraception (barrier method of birth control) prior to study entry and for
the duration of study participation. Men should use adequate birth control
for at least six months after the last administration of sorafenib
•Signed informed consent prior to any study specific procedures
•Estimated life expectancy of at least 12 weeks.
•Compliance and geographic proximity that allow adequate follow-up.

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

•Any prior systemic anticancer therapy including cytotoxic therapy, targeted
agents, experimental therapy (treatment within the last 30 days with a
drug that has not received regulatory approval for any indication at the
time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC
•Any participation in a clinical trial 30 days prior to study entry and
concomitantly to the study
•Cardiac disease: Congestive heart failure > class II NYHA. Patients must
not have unstable angina (angina symptoms at rest) or new-onset angina
(began within the last 3 months) or myocardial infarction within the past 6
months
•Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
•Uncontrolled hypertension defined as systolic blood pressure > 150 mm
Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
•Documented brain metastases (unless the patient has completed
successful local therapy for brain metastases and has been off
corticosteroids for at least 4 weeks before study enrolment). Brain imaging
(CT scan/MRI) is required in symptomatic patients to rule out brain
metastases, but is not required in asymptomatic patients.
•Known HIV infection or chronic hepatitis B or C
•Active clinically serious infections > CTCAE Grade 2
•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 enrolment.
•Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks
of first dose of study drug
•Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first
dose of study drug
•Evidence or history of bleeding diathesis or coagulopathy
•Therapeutic anticoagulation with vitamin K antagonists such as
phenprocoumon, warfarin, or with heparins or heparinoids. Low dose
anticoagulation is permitted
•Serious, non-healing wound, ulcer, or bone fracture
•Major surgery, open biopsy or significant traumatic injury within 4 weeks
of first dose of study drug
•Known or suspected allergy to sorafenib, carboplatin or pemetrexed
•Previous or current cancer that is distinct in primary site or histology from
NSCLC except cervical cancer in-situ, treated basal cell carcinoma,
superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3
years prior to study entry
•Substance abuse, medical, psychological or social conditions that may
interfere with the patients participation in the study
•Significant weight loss (> or equal 10% body weight during preceeding 6
weeks)
•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).
•Inability or unwillingness to take folic acid or vitamin B12 supplementation.
•Recent (within 30 days of enrolment) or concurrent yellow fever vaccination
•Serious concomitant systemic disorder that, in the opinion of the
investigator, would compromise the patient’s a

Study & Design

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