Clinical trial NCT00014547: BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
Official title: Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
recurrent small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BBR 3464 in treating patients who have metastatic small cell lung cancer that has not responded to previous treatment.

Detailed description: OBJECTIVES: I. Determine the efficacy of BBR 3464 in terms of response rate in patients with sensitive or refractory metastatic small cell lung cancer. II. Determine the duration of response and time to progression in patients treated with this drug. III. Determine the overall survival of patients treated with this drug. IV. Determine the incidence and severity of toxic effects of this drug in this patient population. V. Determine the pharmacokinetics of this drug in this patient population.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (refractory vs sensitive). Patients receive BBR 3464 IV over 1 hour on day 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease may receive up to 6 courses of therapy. Patients without progressive disease after 6 courses may continue treatment at the investigator's discretion. Patients are followed every 9 weeks for 3 years.

PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic small cell lung cancer (SCLC) Must have sensitive or refractory disease after first-line chemotherapy Refractory Progressive or stable disease during chemotherapy Relapse after a response during treatment Relapse after a response within 3 months after completing chemotherapy Sensitive Relapse after a response of at least 3 months duration after completing chemotherapy At least 1 measurable lesion No previously irradiated lesions No symptomatic brain or leptomeningeal metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN ALT or AST no greater than 2.5 times ULN Albumin at least 2.5 g/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min (60 mL/min if treated with prior cisplatin therapy) Cardiovascular: No congestive heart failure or angina pectoris (even if medically controlled) No myocardial infarction within the past year No uncontrolled hypertension or arrhythmia Other: No other serious illness or medical condition No history of significant neurologic disorder (other than metastatic disease or psychiatric disorder) No uncontrolled infection No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, carcinoma in situ or the cervix, or other surgically cured cancer No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy for SCLC and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for carboplatin at doses of at least 500 mg/m2 or AUC more than 7 mg/mL) and recovered No more than 1 prior chemotherapy regimen No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal therapy for SCLC and recovered No concurrent steroids for brain metastasis No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy except palliative local radiotherapy for non-target lesions Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 30 days since prior investigational drugs and recovered No other concurrent anti-cancer therapy No other concurrent investigational drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants, Inc
state: Alabama
city: Fayetteville
country: United States
facility: Highlands Oncology Group, P.A.
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Southington
country: United States
facility: Office of Peter D. Byeff
state: Connecticut
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Cancer Pavilion
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology/Oncology P.C.
state: Indiana
city: Lexington
country: United States
facility: University Hospital Lexington
state: Kentucky
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Barnard Cancer Center
state: Missouri
city: Princeton
country: United States
facility: Theradex
state: New Jersey
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Columbus
country: United States
facility: Cancer Services
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Oncology Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: Cancer Center at the University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center
state: Virginia
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Mark A. Socinski, MD
role: STUDY_CHAIR
References: