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

Lung Cancer Clinical Trial

Official title:

Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003696
• Other study ID #: CDR0000066803
• Secondary ID: CKVO-9802DUT-KWF
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 16, 2013
• Start date: October 1998

Study information

• Verified date: November 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• paclitaxel

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Commissie Voor Klinisch Toegepast Onderzoek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Response rate			No
Secondary	Duration of response			No
Secondary	Toxicity			Yes