BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment

NCT00014547 | Unknown Phase 2

• 4 other identifiers: CDR0000068555THERADEX-TPT-II-04NOVUSPHARMA-TPT-II-04NCI-V01-1653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 18

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Interventions

BBR 3464 DRUG

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Theradex: lead

Study Sites (18)

Clinical Research Consultants, Inc

Hoover, Alabama, 35216, United States

Location

Highlands Oncology Group, P.A.

Fayetteville, Arkansas, 72703, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Office of Peter D. Byeff

Southington, Connecticut, 06489, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Indiana Cancer Pavilion

Indianapolis, Indiana, 46202, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

University Hospital Lexington

Lexington, Kentucky, 40536-0084, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Theradex

Princeton, New Jersey, 08543, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Cancer Services

Columbus, Ohio, 43214, United States

Location

Oklahoma Oncology Inc.

Tulsa, Oklahoma, 74104, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

BBR 3464

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark A. Socinski, MD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: March 11, 2004
• Study Start: November 1, 2000
• Last Updated: July 24, 2008

Record last verified: 2002-01

Locations

US (18)