Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003917
• Other study ID #: SKF1598
• Secondary ID: CWRU-SKF-1598SB-
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: January 8, 2014
• Start date: March 1999
• Est. completion date: November 2001

Study information

• Verified date: January 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2001
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Medical College of Georgia Hospital and Clinics	Augusta	Georgia
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Cooper Cancer Institute	Camden	New Jersey
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Oncology Clinic, P.C.	Colorado Springs	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Texas Cancer Care	Fort Worth	Texas
United States	Pacific Coast Hematology/Oncology Medical Group	Fountain Valley	California
United States	Shands Cancer Center	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Penn State Geisinger Cancer Center	Hershey	Pennsylvania
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Oncology and Hematology Associates, Inc.	Indianapolis	Indiana
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Scripps Clinic	La Jolla	California
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Central Pennsylvania Hematology & Medical Oncology Associates, PC	Lemoyne	Pennsylvania
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California
United States	Joe Arrington Cancer Center	Lubbock	Texas
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	Alton Ochsner Medical Foundation Hospital	New Orleans	Louisiana
United States	Office of Michael E. Lee	Norfolk	Virginia
United States	Baptist Hospital- Pensacola	Pensacola	Florida
United States	Veterans Affairs Medical Center - Phoenix (Hayden)	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy Hospital	Pontiac	Michigan
United States	Southwest Cancer Care	Poway	California
United States	Brown University Oncology Group	Providence	Rhode Island
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Hematology & Oncology Associates of Virginia	Richmond	Virginia
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	University of California Davis Cancer Center	Sacramento	California
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California
United States	Sidney Kimmel Cancer Center	San Diego	California
United States	Santa Fe Hematology/Oncology	Santa Fe	New Mexico
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Cooper Hospital/University Medical Center	Voorhees	New Jersey
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Salem Research	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	Smith Kline Beecham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation