Health Condition 1: null- Advanced Stage III/IV or Recurrent Non Small Cell Lung Cancer
Conditions
Interventions
Intervention1: GSK584433: 5 mcg/kg/day administered via SC injection or IV infusion (based on standard of care at each study center). Begin on the third day after the administration of cytotoxic chemo
Sponsors
GlaxoSmithKline Research and Development Limited
PPD Pharmaceutical Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject provides written informed consent. 2. Subject is male or female at least 18 years of age (unless local regulations require an older age). 3. Subject has histologically-confirmed (cytological specimens obtained by bronchial washing, bronchial brushing, or fine-needle aspiration are acceptable), unresectable, stage IIIB NSCLC, with pericardial or pleural effusion; stage IV NSCLC; or recurrent NSCLC. Evaluation of effusions (ie, with cytology) is not required if a diagnosis of NSCLC has been otherwise histologically confirmed. Subjects with cytologically-confirmed disease may be allowed after consultation with the medical monitor. 4. Subject is chemotherapy naive or has not received more than 1 prior regimen of chemotherapy. 5. Subject requires treatment with paclitaxel plus carboplatin every 3 weeks for 6 cycles. 6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Subject has a life expectancy of more than 5 months. 8. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening. 9. Female subjects of childbearing potential (ie, not surgically sterile and/or not postmenopausal for at least 12 months) must be practicing adequate contraception throughout their participation in the study, including the screening and follow up periods. Methods of adequate contraception include abstinence, nonsystemic hormonal barrier, and double-barrier method (eg, condom or occlusive cap plus nonosynol-9). 10. Subjects must have adequate organ function, as defined by the following baseline values: a. Hematological function i. ANC greater or equal to 1.5 x 109/L ii. Platelets greater or equal to 75 x 109/L iii. Hemoglobin greater or equal to 9 g/dL b. Renal function i. Creatinine clearance greater or equal to 40 mL/min (calculated by modified Cockcroft-Gault formula [Rostoker et al 2007]) ii. Serum creatinine less than or equal 1.5 x upper limit of normal (ULN) c. Hepatic function i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present) ii. Alkaline phosphatase less than or equal to 2.0 x ULN (or less than or equal to 5.0 x ULN if liver or bone metastases are present) iii. Serum bilirubin less than or equal 1.5 x ULN 11. Subjects with a history of brain metastases are eligible if definitive surgery and/or radiation therapy has been administered, no further treatment is planned, and the subject is clinically stable for at least 2 weeks before randomization
Exclusion criteria
Exclusion criteria: 1. Subject received chemotherapy, lithium, or any other medication known to significantly affect ANC within 4 weeks before randomization. 2. Subject has peripheral neuropathy of grade 2 or greater. 3. In the opinion of the investigator, subject has clinically significant third-space fluid collection (eg, ascites or pleural effusions) that cannot be controlled by drainage or other procedures before study enrollment. 4. Subject has evidence of a significant medical condition or laboratory finding that, in the opinion of the investigator, would make it undesirable for the subject to participate in the study. Examples include, but are not limited to, the following: a. Congestive heart failure, as assessed by the investigator based on the practice standards at each study center b. Myocardial infarction within 6 months before randomization c. Significant neurological or psychiatric disorder that would impact study participation, including but not limited to seizures from brain metastases, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, intraabdominal abscess, and coagulopathy d. Superior vena cava syndrome, unless controlled with radiotherapy e. Uncontrolled type 1 or type 2 diabetes mellitus f. Sickle cell disease g. Any contraindication to high dose corticosteroid therapy, such as herpes simplex, herpes zoster, hepatitis, or other disease h. Subjects requiring immunosuppressive agents 5. Subject has a known hypersensitivity to paclitaxel, carboplatin, GCSF, or any of their excipients, including fructose. 6. Subject has a known hypersensitivity to E. coli derived proteins. 7. Subject has an active infection that requires systemic treatment or any uncontrolled infection less than or equal to 14 days before randomization. 8. Subject has had a bone marrow transplant. 9. Subject has received prior treatment with an investigational or marketed rhGCSF (eg, PEG-GCSF) within 4 weeks before randomization. 10. Subject has had major surgery requiring general anesthesia and a significant incision (eg, larger than what is required for central venous catheter placement, percutaneous feeding tube, or biopsy) 28 days before randomization or minor surgery (excluding central venous catheter placement, percutaneous feeding tube, or biopsy) 14 days before randomization. Subjects must have recovered from any surgery-related toxicity. 11. Subject is a female who is pregnant or lactating. 12. Subject has a psychological, familial, sociological, or geographical condition that does not permit compliance with the protocol. 13. Subject is unwilling or unable to follow the procedures required by the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. medullary bone pain 2. laboratory abnormalities of alkaline phosphatase, uric acid, and lactate dehydrogenase 3. severe neutropenia 4. febrile neutropenia 5. infection 6. immunogenicity Timepoint: Cycle 1 and Cycle 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute neutrophil count 2. medullary bone pain 3. laboratory abnormalities of alkaline phosphatase, uric acid, and lactate dehydrogenase 4. severe neutropenia 5. febrile neutropenia 6. infection Timepoint: Cycle 1 to cycle 6 | — |
Countries
India, Thailand
Contacts
Public ContactArun Sundriyal
Outcome results
None listed