Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087048
Recruitment Status : Terminated (Slow accrual)
First Posted : July 12, 2004
Last Update Posted : March 22, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

July 8, 2004
July 12, 2004
March 22, 2016
April 2004
February 2006   (Final data collection date for primary outcome measure)
Overall survival
Not Provided
Complete list of historical versions of study NCT00087048 on Archive Site
  • Safety and toxic effects
  • Recurrence-free survival
  • Time to response and tumor response
  • Quality of life
Not Provided
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Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.



  • Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride.


  • Determine the safety and toxic effects of this drug in these patients.
  • Determine the recurrence-free survival of patients treated with this drug.
  • Determine time to response and tumor response in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter.

Patients are followed at 7-14 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
Drug: topotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2006
February 2006   (Final data collection date for primary outcome measure)


  • Histologically confirmed small cell lung cancer (SCLC)

    • Recurrent extensive stage disease
    • No mixed histology
  • Measurable disease

    • At least 1 bidimensionally measurable, non-central nervous system (CNS), indicator lesion confirmed by CT scan or MRI
  • Sensitive disease

    • Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
  • Eligible for high-dose chemotherapy
  • No symptomatic brain metastases affecting performance status



  • 18 and over

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • At least 2 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hematocrit > 35% (without transfusion)


  • Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times normal*
  • Alkaline phosphatase ≤ 2 times normal*
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin > 2.5 g/dL
  • Hepatitis B surface antigen negative
  • No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver metastases are present


  • Creatinine clearance ≥ 40 mL/min


  • No history of cardiac arrhythmias
  • No congestive heart failure
  • No ischemic heart disease
  • No stroke or other embolic disease requiring daily treatment that would preclude study participation


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No known seizure disorder
  • No active infection requiring systemic therapy within the past 2 weeks
  • No known hypersensitivity to topotecan hydrochloride
  • No medical or psychiatric condition that would preclude study participation
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
  • No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
  • No prior topotecan hydrochloride

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 2 months since prior investigational agent
  • No other concurrent investigational agent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP