Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

NCT00003917 | Completed Phase 3 DMC

• 4 other identifiers: SKF1598CWRU-SKF-1598SB-104864-A/396NCI-G99-1524
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 53

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.

Conditions

Lung Cancer

Keywords

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

Interventions

topotecan hydrochloride 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 limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Smith Kline Beecham: collaborator

Study Sites (53)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Pacific Coast Hematology/Oncology Medical Group

Fountain Valley, California, 92708, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Veterans Affairs Medical Center - West Los Angeles

Los Angeles, California, 90073, United States

Location

Southwest Cancer Care

Poway, California, 92064, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Sidney Kimmel Cancer Center

San Diego, California, 92121, United States

Location

Oncology Clinic, P.C.

Colorado Springs, Colorado, 80909, United States

Location

Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Baptist Hospital- Pensacola

Pensacola, Florida, 32522, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Medical College of Georgia Hospital and Clinics

Augusta, Georgia, 30912-3620, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Oncology and Hematology Associates, Inc.

Indianapolis, Indiana, 46219, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Alton Ochsner Medical Foundation Hospital

New Orleans, Louisiana, 70121, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Joseph Mercy Hospital

Pontiac, Michigan, 48341-2985, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 08103, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Cooper Hospital/University Medical Center

Voorhees Township, New Jersey, 08043, United States

Location

Santa Fe Hematology/Oncology

Santa Fe, New Mexico, 87505, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Salem Research

Winston-Salem, North Carolina, 27103, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Penn State Geisinger Cancer Center

Hershey, Pennsylvania, 17033, United States

Location

Central Pennsylvania Hematology & Medical Oncology Associates, PC

Lemoyne, Pennsylvania, 17043-1440, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Brown University Oncology Group

Providence, Rhode Island, 02912, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, 29303, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

Sarah Cannon-Minnie Pearl Cancer Center

Nashville, Tennessee, 37203, United States

Location

Texas Cancer Care

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Joe Arrington Cancer Center

Lubbock, Texas, 79410, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Office of Michael E. Lee

Norfolk, Virginia, 23502, United States

Location

Hematology & Oncology Associates of Virginia

Richmond, Virginia, 23226, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (1)

• Eckardt JR, von Pawel J, Pujol JL, Papai Z, Quoix E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007 May 20;25(15):2086-92. doi: 10.1200/JCO.2006.08.3998.

  PMID: 17513814 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Nathan Levitan, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 14, 2004
• Study Start: March 1, 1999
• Primary Completion: November 1, 2001
• Study Completion: November 1, 2001
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (53)