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Status unknownNCT00003696Updated Sep 17, 2013

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

A Phase 3 interventional study of carboplatin and cyclophosphamide in Lung Cancer, sponsored by Commissie Voor Klinisch Toegepast Onderzoek. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Commissie Voor Klinisch Toegepast Onderzoek · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • extensive stage small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 250 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Commissie Voor Klinisch Toegepast Onderzoek is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
250 participants (estimated)

Interventions

  • Drugcarboplatin
  • Drugcyclophosphamide
  • Drugdoxorubicin hydrochloride
  • Drugetoposide
  • Drugpaclitaxel
06

What researchers measure

Primary outcomes

  1. Progression-free survival

Secondary outcomes

  1. Overall survival

  2. Response rate

  3. Duration of response

  4. Toxicity

07

Study locations

1 site
  • Vrije Universiteit Medisch Centrum
    Amsterdam, 1007 MB, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003696
Lead sponsor
Commissie Voor Klinisch Toegepast Onderzoek
First posted
Jan 27, 2003
Start date
Oct 1998
Last update
Sep 17, 2013

Study contacts

Egbert F. Smit, MD
study chair · Free University Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2001. You cannot join it, but the record below documents what was studied.

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