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Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase II Study Of BBR 3464 As Treatment In Patients With Sensitive Or Refractory Small Cell Lung Cancer After One Prior Chemotherapy Regimen

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

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark A. Socinski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Massey Cancer Center Richmond, Virginia  23298-0037
Washington University Barnard Cancer Center Saint Louis, Missouri  63110
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Highlands Oncology Group, P.A. Fayetteville, Arkansas  72703
Oklahoma Oncology Inc. Tulsa, Oklahoma  74104
Louisiana Oncology Associates Lafayette, Louisiana  70506
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Cancer Services Columbus, Ohio  43214
Theradex Princeton, New Jersey  08543
Clinical Research Consultants, Inc Hoover, Alabama  35216
Office of Peter D. Byeff Southington, Connecticut  06489
Indiana Cancer Pavilion Indianapolis, Indiana  46202
University Hospital Lexington Lexington, Kentucky  40536-0084