Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer
Condition: Recurrent Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Intervention: Laboratory Biomarker Analysis; Pegylated Irinotecan; Pharmacological Study
Intervention description: Correlative studies; Given IV; Correlative studies
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients
      with small cell lung cancer that has returned after a period of improvement. Pegylated
      irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent granted prior to initiation of any study-specific screening
             procedures, given with the understanding that the patient has the right to withdraw
             from the study at any time, without prejudice

          -  Histologic or cytologic diagnosis of SCLC (Note: patients with mixed histology are not
             eligible)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Presence of measurable disease defined as >= 1 lesion whose longest diameter can be
             accurately measured as >= 20 mm with conventional techniques or as >= 10 mm with
             spiral computed tomography (CT)

          -  Previously treated SCLC with only one prior treatment regimen
             (cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin
             [EP] is acceptable)

          -  Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal
             therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria for
             Adverse Events (CTCAE) version 4.0 grade =< 1, except for diarrhea (which must be
             grade 0 without supportive antidiarrheal medications) and alopecia (any grade)

          -  Platelet count >= 100 x 10^9/L

          -  Hemoglobin (Hgb) >= 9 gm/dL

          -  Absolute neutrophil count (ANC) >= 1500/uL

          -  Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured
             or calculated with Cockcroft-Gault formula

          -  Serum total bilirubin =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN or =< 5
             x ULN if caused by liver metastasis

          -  Women of childbearing potential must have a negative pregnancy test performed within
             seven days prior to the start of study drug; male and female subjects of child-bearing
             potential must agree to use double-barrier contraceptive measures, or avoidance of
             intercourse during the study and for 6 months after last investigational drug dose
             received

        Exclusion Criteria:

          -  Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks
             (6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined
             treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks, hormonal
             therapy within 1 week prior to day 1 cycle 1

          -  Prior treatment with a topoisomerase-I inhibitor (e.g., topotecan, irinotecan)

          -  Prior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless
             diagnosed and definitively treated more than 5 years prior to enrollment

          -  Substance abuse, medical, psychological or social conditions that may, in the opinion
             of the Investigator, interfere with the patient's participation in the study or
             evaluation of the study results

          -  Known human immunodeficiency virus (HIV) infection

          -  Pregnancy or breast-feeding

          -  Concurrent administration or received cytochrome P450, family 3, subfamily A,
             polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks prior to the first day of
             study drug treatment

          -  Patients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea
             of any severity grade; patients who are using chronic anti-diarrheal supportive care
             (more than 3 days/week) to control diarrhea in the 28 days prior to study entry

          -  Major surgery < 4 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy,
             etc) < 2 weeks prior to the first day of study defined treatment

          -  Have central nervous system (CNS) metastases (unless the patient has completed
             successful local therapy for CNS metastases and has been off corticosteroids for at
             least 4 weeks before starting study therapy); brain imaging is required in symptomatic
             patients to rule out brain metastases, but is not required in asymptomatic patients

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Unwilling or unable to follow protocol requirements