A PHASE 2, RANDOMIZED, OPEN LABEL STUDY OF FIGITUMUMAB (CP 751,871)PLUS CISPLATIN (OR CARBOPLATIN) AND ETOPOSIDE, VERSUS CISPLATIN (OR CARBOPLATIN) AND ETOPOSIDE ALONE, AS FIRST LINE TREATMENT IN PATIENTS WITHEXTENSIVE STAGE DISEASE SMALL CELL LUNG CANCER
- Conditions
- FIRST LINE TREATMENT IN PATIENTS WITH EXTENSIVE STAGE DISEASE SMALL CELL LUNG CANCERMedDRA version: 12.0Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage
- Registration Number
- EUCTR2009-012857-39-BG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Unless compelling reason, to be agreed between Investigator and Sponsor prior to randomization, patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1.Male or females =18 years of age.
2.Histologically confirmed SCLC. Tumor tissue is required preferably from available specimens (section/slides) for additional study purposes. New biopsy not required unless existing sample is not available.
3.Extensive stage disease as defined by any of the following criteria:
•Extrathoracic metastasis;
•Malignant pleural effusion;
•Bilateral or contralateral supraclavicular lymphadenopathy.
4.Measurable disease as defined by RECIST 1.1. Baseline measurements/evaluations must be completed within 28 days prior to randomization. Brain metastasis should not be considered measurable/target lesions.
5.At least one week since last radiotherapy and adequate recovery from major surgery with wound healing completed. Patients must have recovered to NCI CTCAE v4.0= Grade 1 from all acute toxicities (excluding any Grade toxicity that is not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the investigator.
6.ECOG performance status 0 or 1.
7.Total IGF-1 >120 ng/mL.
8.Patients must have adequate organ function as determined by the following criteria. These must be determined within 7 days prior to randomization:
a.Absolute neutrophil count (ANC) =1.5 x 10 (to the power of 9)/L;
b.White blood cell (WBC) =4000 cells/ml;
c.Platelet count =100 x 10 (to the power of 9)/L;
d.Hemoglobin =8 g/dl;
e.Glycosylated hemoglobin (HgbA1c) <5.7%;
f.Creatinine clearance =60ml/min (actual or calculated using the Cockcroft Gault formula using actual body weight, see protocol Section 5.3.3.3);
g.BUN =25 mg/dl; or Urea =8.9 mmol/L;
h.Serum aspartate aminotransferase (AST; serum glutamate oxalate transferase [SGOT]), serum alanine aminotransferase (ALT; serum glutamate pyruvate transferase [SGPT]), and alkaline phosphatase =2.5 x ULN, or =5 x ULN if liver abnormalities are due to underlying malignancy;
i.Total bilirubin =1.5 x ULN (or =3 x ULN in patients with confirmed UGT1A1 promoter polymorphism or Gilbert syndrome).
9.Female patients must not be pregnant or nursing. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter (or longer if required by local regulation). All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients with partners of childbearing potential must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter (or longer if required by local regulation). The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.
10.Patient must be willing and able to comply with scheduled visits (including follow up visits), treatment plans, laboratory tests, collection of patient reported outcomes and other study procedures.
11.Written, voluntary, signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial before enrollment must be provided.
A
Patients presenting with any of the following will not be included in the study:
1.Any prior systemic therapy for SCLC.
2.Investigational therapies (targeted or vaccine) for other than SCLC, unless otherwise agreed by investigators and sponsor, will require an appropriate wash out period before enrollment unless otherwise agreed by investigator and sponsor. Must not be simultaneously enrolled in another therapeutic clinical trial for any condition.
3.Patients with symptomatic central nervous system (CNS) metastases are not permitted.
a.Patients with symptoms suggestive of CNS metastases must undergo radiologic/imaging evaluation at baseline to rule out metastases;
b.Patients with known, asymptomatic CNS lesions are permitted;
c.Patients with stable, treated brain metastasis (eg, whole brain radiation therapy or similar) are eligible provided they are on a tapering dose of corticosteroids (see exclusion criteria 7; or are not on corticosteroid therapy).
4.Medically significant hemoptysis, defined as bright red blood of ½ teaspoon or more within 4 weeks prior to randomization;
5.No other active invasive malignancies (previous malignancies are allowed if occurred =3 years prior to randomization or current in situ malignancies such as, in situ carcinoma of the cervix, of the uterus, or basal or squamous cell carcinoma of the skin).
6.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to:
a.Uncontrolled hypertension, uncontrolled diabetes or insulin dependent diabetes;
b.Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure. The requirement for inotropic support or a serious uncontrolled cardiac arrhythmia (atrial flutter/afibrillation) within the past 3 years;
c.Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HBC) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection, but is required for patients who do;
d.Pre existing peripheral neuropathy > CTCAE Grade 2;
e.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol.
7.No use of any concomitant medication that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results. This includes but is not limited to:
a.Requirement for chronic treatment with systemic corticosteroids at doses higher than physiologic replacement (ie, prednisone equivalent 5 mg/day) or other immunosuppressive therapy during study participation. Previous steroid treatment must be discontinued within 1 week prior to study start. Low dose steroid use for the control of nausea and vomiting will be allowed. The use of corticosteroids for the prophylaxis or treatment of nausea and vomiting, or as chemotherapy pre medication, will be allowed at the discretion of the investigator;
b.Previous or concurrent therapy with any IGF IR inhibitor;
c.Use of growth hormone agonist or antagonist, or aminoglycoside antibiotics (neph
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method