Combination Chemotherapy in Treating Patients Who Have 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: NCT00003696
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

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 most effective for extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: paclitaxel Phase 3

Detailed Description:


  • Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer.
  • Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3).

Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks.
  • Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks.

Patients with stable or responding disease are treated for up to 5 courses.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
Study Start Date : October 1998

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Response rate
  3. Duration of response
  4. Toxicity

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 proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases
  • Measurable or evaluable disease

    • Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable



  • Over 18

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 2,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases)


  • Creatinine clearance at least 60 mL/min


  • No cardiac failure or rhythm disturbances requiring medication


  • No history of hypersensitivity to castor oil
  • No active uncontrolled infection
  • No nonmalignant disease presenting a poor medical risk
  • Not pregnant
  • Fertile patients must use effective contraception during and for 3 months after the study


Biologic therapy:

  • No concurrent immunotherapy


  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy


  • See Disease Characteristics
  • Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field)


  • Not specified

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): NCT00003696

Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
Study Chair: Egbert F. Smit, MD Free University Medical Center Identifier: NCT00003696     History of Changes
Other Study ID Numbers: CDR0000066803
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: November 2001

Keywords provided by National Cancer Institute (NCI):
extensive stage 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
Liposomal doxorubicin
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic