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

Commissie Voor Klinisch Toegepast Onderzoek

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Drug: carboplatin; Drug: etoposide; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00003696

CKVO-9802

CDR0000066803

EU-98059

DUT-KWF-CKVO-9802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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