Clinical trial NCT00472771: INNO-206 in Patients With Small Cell Lung Cancer (SCLC)
Official title: A Phase II, Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: Recurrent extensive small cell lung cancer
Lead sponsor: CytRx
Sponsor class: INDUSTRY
First posted: 2007-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.

Detailed description: This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in adult patients with recurrent extensive small cell lung cancer sensitive to first-line platinum-based therapy. The primary objective of the study is to determine the objective overall response rate. Secondary objectives include evaluating the treatment-related toxicities in this patient population and determining the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients.

Eligibility criteria: Inclusion Criteria:

* Be ≥18 years old.
* Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at the time of enrollment into the study.
* Have responded to first-line platinum-based chemotherapy, but progressed or relapsed ≥60 days after completion of first-line therapy.
* Have measurable disease defined by RECIST.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
* Have an estimated life expectancy of ≥4 weeks.
* Be male or non-pregnant, non-lactating female patients. Patients who are fertile must agree to use an effective barrier method of birth control to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication.
* Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).
* Have adequate organ function.

Exclusion Criteria:

* Are pregnant or lactating.
* Have received prior anthracycline therapy.
* Have participated in any investigational drug study within 30 days prior to study entry.
* Have received radiotherapy within 2 weeks of treatment in this study.
* Have not recovered from acute toxicity of all previous therapy prior to enrollment.
* Have a history of a malignancy other than SCLC. Exceptions to this include: curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix, or prior low-grade, localized prostate cancer (Gleason score ≤6); or a history of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.
* Have symptomatic central nervous system (CNS) metastases.
* Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances, etc.) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
* Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
* Have received radiotherapy with \>25% involvement of the bone marrow within 6 weeks prior to study start.
* Have a known hypersensitivity to doxorubicin, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N-acetyltryptophane.

Primary outcomes:
measure: To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
Secondary outcomes:
measure: To determine the rates of stable disease and progressive disease.
measure: To determine time to progression.
measure: To determine progression-free survival.
measure: To determine overall survival.
measure: To evaluate the treatment-related toxicities in this patient population.
measure: To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Kettering
country: United States
facility: Dayton Oncology and Hematology
state: Ohio
city: Middletown
country: United States
facility: Signal Point Hematology/Oncology, Inc.
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
affiliation: University of Chicago
name: Michael Maitland, MD
role: PRINCIPAL_INVESTIGATOR
References: