Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer

NCT01876446 | Completed Phase 2 Results DMC

• 3 other identifiers: I 225612NCI-2013-01142P30CA016056
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 18 Week Progression-free Survival Rate

  The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.

  Time from registration to the date of first documented disease progression or death, assessed at 18 weeks

Secondary Outcomes (5)

• Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 30 days

• Mean Duration of Response

  Time from registration to death due to any cause, assessed up to 3 years

• Best Response

  Up to 30 days

• Median Overall Survival

  Time from registration to death due to any cause, assessed up to 3 years

• Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0

  Up to 30 days

Study Arms (1)

Treatment (pegylated irinotecan NKTR 102)

EXPERIMENTAL

Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Other: Laboratory Biomarker Analysis; Drug: Pegylated Irinotecan; Other: Pharmacological Study

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (pegylated irinotecan NKTR 102)

Pegylated Irinotecan DRUG

Given IV

Also known as: NKTR 102, PEG-Irinotecan

Treatment (pegylated irinotecan NKTR 102)

Pharmacological Study OTHER

Correlative studies

Treatment (pegylated irinotecan NKTR 102)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Nektar Therapeutics: collaborator

Study Sites (3)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Linden Oaks Medical Campus

Rochester, New York, 14625, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

etirinotecan pegol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

Adrienne.Groman@RoswellPark.org

716-845-2300

Study Officials

• Hongbin Chen, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 12, 2013
• Study Start: August 29, 2013
• Primary Completion: July 18, 2017
• Study Completion: February 24, 2020
• Last Updated: March 17, 2020
• Results First Posted: September 6, 2019

Record last verified: 2020-03

Locations

US (3)