None listed
Conditions
Interventions
Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles + carboplatin intravenously every 21 days for up to six cycles + paclitaxel intravenously every 21 days for up to six cycles.
Group name:Arm B Type of group
Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles + paclitaxel intravenously every 21 days for up to six cycles.
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma. • Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease • No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed =12 months prior to randomization • Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved to CTC Grade 1 (NCI CTCAE v3.0) • Age =18 years • ECOG performance status (PS) 0 or 1 • Adequate organ function as determine by the following criteria: a. Absolute neutrophil count (ANC) =1.5 x 109/L. b. Platelet count =75 x 109/L. c. Hemoglobin =8 g/dl. d. Serum creatinine =1.5 x upper limit of normal (ULN). e. Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) =5 x ULN, or =10 x ULN if liver abnormalities are due to underlying malignancy. f. Total bilirubin =1.25 x ULN • Female patients may 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. • Written, voluntary informed consent must be provided • Patients with symptomatic central nervous system (CNS) metastases are not permitted. Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases. Patients with known, asymptomatic CNS lesions are permitted. Patients with stable, treated brain metastasis (e.g. whole brain radiation therapy or similar) are permitted (off steroid medication) • No 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
Exclusion criteria
Exclusion criteria: • Patients with a primary histology of adenocarcinoma NSCLC and those with unknown or unspecified (Not otherwise specified) NSCLC histology will be excluded • Patients with symptomatic central nervous system (CNS) metastases are not permitted. • Enrollment in another therapeutic clinical trial is not permitted • Previous or concurrent therapy with any IGF1R inhibitor, growth hormone agonist or antagonist is not permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. Measure:Overall Survival (OS) Timepoints:Baseline until death, assessed monthly after end of treatment, up to 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions). Measure:Progression-Free Survival (PFS) Timepoints:At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months ; Outcome name:Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Measure:Percentage of Participants With Objective Response (OR) Timepoints:At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months ; Outcome name:EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 Not at all to 4 Very much; 2 questions used 7-point scale (1 very poor to 7 Excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or gr | — |
Countries
Australia, Austria, Brazil, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea South, Poland, Russian Federation, Spain, Switzerland, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactGreta Santillana
PFIZER S.A.
Outcome results
None listed