Combination Chemotherapy in Treating Patients With 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: NCT00041015
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 9, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: etoposide Drug: topotecan hydrochloride Phase 3

Detailed Description:


  • Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
  • Compare the response rates, response duration, and time to progression in patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the patient-perceived disease status and well being in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
  • Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.

Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.

Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
Study Start Date : September 2001
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
Drug: cisplatin Drug: topotecan hydrochloride
Experimental: Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
Drug: cisplatin Drug: etoposide

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed extensive stage small cell lung carcinoma (SCLC)
  • No prior chemotherapy for SCLC OR
  • No chemotherapy within 5 years of diagnosis of SCLC
  • Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing
  • No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI

    • Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Hemoglobin at least 9.0 g/dL
  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3
  • Neutrophil count at least 1,500/mm3


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)


  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No pre-existing renal impairment that would preclude cisplatin use


  • No clinical evidence of any gastrointestinal (GI) conditions including:

    • Removal of a portion of the stomach
    • History of recent obstruction of the GI tract
    • GI autonomic neuropathy
    • Ulcerative colitis
    • Crohn's disease
    • Malabsorption syndrome
    • Treatment with cyclosporine that would alter absorption or GI motility
  • No other conditions that would preclude absorption of oral topotecan


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study
  • No active infection
  • No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer
  • No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance
  • No prior allergic reactions to compounds chemically related to study drugs
  • No pre-existing hearing impairment that would preclude cisplatin use
  • No overall medical condition for which study drugs would be inappropriate


Biologic therapy:

  • No concurrent immunotherapy for SCLC


  • See Disease Characteristics
  • No other concurrent chemotherapy for SCLC

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy for SCLC


  • See Disease Characteristics
  • At least 24 hours since prior radiotherapy with no expected bone marrow suppression
  • Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium)
  • No concurrent radiotherapy for SCLC
  • No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator


  • At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient)


  • More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs
  • No other concurrent investigational therapy for SCLC
  • No concurrent cyclosporine
  • No concurrent drugs that would preclude absorption of oral topotecan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041015

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Nathan Levitan, MD Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00041015     History of Changes
Other Study ID Numbers: SKF1501
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

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
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors