This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(Slow accrual)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center Identifier:
First received: July 8, 2004
Last updated: March 21, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Lung Cancer Drug: topotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Safety and toxic effects
  • Recurrence-free survival
  • Time to response and tumor response
  • Quality of life

Enrollment: 1
Study Start Date: April 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00087048

United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00087048     History of Changes
Other Study ID Numbers: CDR0000372872
Study First Received: July 8, 2004
Last Updated: March 21, 2016

Keywords provided by Case Comprehensive Cancer Center:
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on August 17, 2017