Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

January 8, 2014 updated by: Case Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

Smith Kline Beecham

Investigators

  • Study Chair: Nathan Levitan, MD, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

November 1, 2001

Study Completion (Actual)

November 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 13, 2004

First Posted (Estimate)

April 14, 2004

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKF1598
  • CWRU-SKF-1598
  • SB-104864-A/396
  • NCI-G99-1524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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