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Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsor: Ireland Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003917
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: topotecan hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 300
Study Start Date: March 1999
Detailed Description:

OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.

OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003917

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Scripps Clinic
La Jolla, California, United States, 92037
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States, 92708
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Sidney Kimmel Cancer Center
San Diego, California, United States, 92121
Southwest Cancer Care
Poway, California, United States, 92064
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
United States, Colorado
Oncology Clinic, P.C.
Colorado Springs, Colorado, United States, 80909
United States, Florida
Baptist Hospital- Pensacola
Pensacola, Florida, United States, 32522
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Shands Cancer Center
Gainesville, Florida, United States, 32610
United States, Georgia
Medical College of Georgia Hospital and Clinics
Augusta, Georgia, United States, 30912-3620
United States, Illinois
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
United States, Indiana
Oncology and Hematology Associates, Inc.
Indianapolis, Indiana, United States, 46219
United States, Louisiana
Alton Ochsner Medical Foundation Hospital
New Orleans, Louisiana, United States, 70121
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
St. Joseph Mercy Hospital
Pontiac, Michigan, United States, 48341-2985
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Cooper Cancer Institute
Camden, New Jersey, United States, 08103
Cooper Hospital/University Medical Center
Voorhees, New Jersey, United States, 08043
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New Mexico
Santa Fe Hematology/Oncology
Santa Fe, New Mexico, United States, 87505
United States, New York
Rochester General Hospital
Rochester, New York, United States, 14621
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Salem Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Central Pennsylvania Hematology & Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States, 17043-1440
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States, 17033
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University Oncology Group
Providence, Rhode Island, United States, 02912
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cancer Care
Fort Worth, Texas, United States, 76104
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
Joe Arrington Cancer Center
Lubbock, Texas, United States, 79410
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Virginia
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States, 23226
Office of Michael E. Lee
Norfolk, Virginia, United States, 23502
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, Wisconsin
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Nathan Levitan, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067097, CWRU-SKF-1598, SB-104864-A/396, NCI-G99-1524
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003917     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Topotecan
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009