Status:
COMPLETED
Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Nektar Therapeutics
Conditions:
Recurrent Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the 18-week progression free survival (PFS) rate of relapsed small cell lung cancer (SCLC) patients treated with NKTR-102 (pegylated irinotecan NKTR 102). SECONDAR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01876446
Start Date
August 29 2013
End Date
February 24 2020
Last Update
March 17 2020
Active Locations (3)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
Rochester General Hospital
Rochester, New York, United States, 14621
3
Linden Oaks Medical Campus
Rochester, New York, United States, 14625