Phase III Randomized Study of Oral Versus Intravenous Topotecan in Patients With Limited or Extensive Small Cell Lung Cancer That Has Relapsed Following First Line Therapy. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Alternate Title

Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCI, Pharmaceutical / IndustryCWRU-SKF-1598
SB-104864-A/396, NCI-G99-1524, NCT00003917


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.

Entry 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
 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

Prior/Concurrent Therapy:

Biologic therapy:
 At least 3 months since prior immunotherapy
 No concurrent immunotherapy for SCLC

 See Disease Characteristics
 No prior topotecan
 Only one prior chemotherapy regimen allowed
 No other concurrent chemotherapy for SCLC

Endocrine therapy:
 See Disease Characteristics

 See Disease Characteristics
 At least 24 hours since prior radiotherapy
 No concurrent radiotherapy for SCLC

 At least 4 weeks since prior surgery 

 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

Patient Characteristics:

 18 and over

Performance status:
 ECOG 0-2

Life expectancy:
 At least 2 months

 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)

 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)

 Creatinine no greater than 1.5 mg/dL OR
 Creatinine clearance at least 60 mL/min

 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

Expected Enrollment


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


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.

Published Results

Eckardt JR, von Pawel J, Pujol JL, et al.: Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol 25 (15): 2086-92, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Seidman Cancer Center at University Hospitals/Case Medical Center

Nathan Levitan, MD, Protocol chair
Ph: 216-844-3695

Registry Information

Official TitleAn 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
Trial Start Date1999-03-15
Registered in ClinicalTrials.govNCT00003917
Date Submitted to PDQ1999-06-03
Information Last Verified2007-05-31
NCI Grant/Contract NumberCA43703

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.