Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abramson Cancer Center at Penn Medicine
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologic or cytologic diagnosis of adenocarcinoma non-small cell lung cancer
Stage IV non-small cell lung cancer or recurrent disease which cannot be approached with curative intent.
Must have recovered from toxic effects of prior chemotherapy
ECOG performance status of 0-1
Life expectancy of at least 12 weeks
Age 18 or greater
Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as \> 20 mm with conventional techniques or \> 10 mm with spiral CT scanning).
Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease.
Patients must be capable of giving informed consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
Bilirubin \< 1.5 mg/dL
Patients must have adequate liver function: AST and ALT \< 2.5 X upper limit of normal, alkaline phosphatase \< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Patients must have adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3
Patients must have adequate renal function: creatinine \<1.5 mg/dL
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Negative serum β-hCG pregnancy test at screening for patients of childbearing potential.
Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
Pregnant or breast-feeding patients, as chemotherapy is thought to present substantial risk to the fetus/infant. Men and women of reproductive potential may not participate in this study unless they have agreed to use an effective contraceptive method while in this study. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 3 months from the date of the last study drug administration
You may not be if
Patients with EGFR or EML4-ALK mutations
ECOG performance status \>1
Patients previously treated with gemcitabine or Abraxane
Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known HIV or Hepatitis C
Clareo Health | Phase II Study of Abraxane and Gemicitabine in Patients With Advanced Adenocarcinoma Non-Small Cell Lung Cancer Progressing After First-Line Platinum-Based Chemotherapy
