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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067097

NCT ID:

NCT00003917

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Ireland Cancer CenterCleveland, Ohio  44106-5065
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Sarah Cannon-Minnie Pearl Cancer CenterNashville, Tennessee  37203
Henry Ford HospitalDetroit, Michigan  48202
Penn State Geisinger Cancer CenterHershey, Pennsylvania  17033
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
University of Texas Medical BranchGalveston, Texas  77555-1329
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Shands Cancer CenterGainesville, Florida  32610
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Evanston Northwestern Health CareEvanston, Illinois  60201
St. Barnabas Medical CenterLivingston, New Jersey  07039
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Scripps ClinicLa Jolla, California  92037
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
University of California Davis Cancer CenterSacramento, California  95817
Scott and White Memorial HospitalTemple, Texas  76508
Cooper Cancer InstituteCamden, New Jersey  08103
Sidney Kimmel Cancer CenterSan Diego, California  92121
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Oncology-Hematology Group of South FloridaMiami, Florida  33176
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Pacific Coast Hematology/Oncology Medical GroupFountain Valley, California  92708
Medical College of Georgia Hospital and ClinicsAugusta, Georgia  30912-3620
Brown University Oncology GroupProvidence, Rhode Island  02912
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Rochester General HospitalRochester, New York  14621
Alton Ochsner Medical Foundation HospitalNew Orleans, Louisiana  70121
Comprehensive Blood and Cancer CenterBakersfield, California  93309
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Southwest Cancer CarePoway, California  92064
Oncology Clinic, P.C.Colorado Springs, Colorado  80909
Baptist Hospital- PensacolaPensacola, Florida  32522
Oncology and Hematology Associates, Inc.Indianapolis, Indiana  46219
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Santa Fe Hematology/OncologySanta Fe, New Mexico  87505
Salem ResearchWinston-Salem, North Carolina  27103
Central Pennsylvania Hematology & Medical Oncology Associates, PCLemoyne, Pennsylvania  17043-1440
Spartanburg Regional Healthcare SystemSpartanburg, South Carolina  29303
Texas Cancer CareFort Worth, Texas  76104
Joe Arrington Cancer CenterLubbock, Texas  79410
Office of Michael E. LeeNorfolk, Virginia  23502
Hematology & Oncology Associates of VirginiaRichmond, Virginia  23226