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Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003696
First Posted: January 27, 2003
Last Update Posted: September 17, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Lung Cancer Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: paclitaxel Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival

Secondary Outcome Measures:
  • Overall survival
  • Response rate
  • Duration of response
  • Toxicity

Estimated Enrollment: 250
Study Start Date: October 1998
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No cardiac failure or rhythm disturbances requiring medication

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

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

Surgery:

  • Not specified
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003696


Locations
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
Investigators
Study Chair: Egbert F. Smit, MD Free University Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00003696     History of Changes
Other Study ID Numbers: CDR0000066803
CKVO-9802
DUT-KWF-CKVO-9802
EU-98059
First Submitted: November 1, 1999
First Posted: January 27, 2003
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Carboplatin
Doxorubicin
Etoposide
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