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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
paclitaxel
Sponsored by
Commissie Voor Klinisch Toegepast Onderzoek
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vrije Universiteit Medisch Centrum

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Response rate
Duration of response
Toxicity

Full Information

First Posted
November 1, 1999
Last Updated
September 16, 2013
Sponsor
Commissie Voor Klinisch Toegepast Onderzoek
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1. Study Identification

Unique Protocol Identification Number
NCT00003696
Brief Title
Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Unknown status
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Commissie Voor Klinisch Toegepast Onderzoek

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Response rate
Title
Duration of response
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egbert F. Smit, MD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands

12. IPD Sharing Statement

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

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