Overview

Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gundersen Lutheran Health System
Treatments:
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer

- Extensive stage disease (i.e., disease beyond the hemithorax and cannot be
encompassed safely by a tolerable radiation field)

- Measurable disease

- Concurrent CNS metastases allowed provided patient remains asymptomatic

- Radiotherapy or surgery for uncontrolled symptoms allowed before study entry

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8 g/dL (transfusion allowed)

Hepatic

- ALT ≤ 2 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN

Renal

- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 60 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past year except adequately treated basal cell or
squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Concurrent corticosteroids for brain metastases allowed

Radiotherapy

- See Disease Characteristics

- Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not
previously irradiated

- No concurrent radiotherapy

Surgery

- See Disease Characteristics