Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status and phase

Unknown

Phase 3

Conditions

Lung Cancer

Treatments

Drug: cisplatin

Drug: carboplatin

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00112710

CDR0000429610

CRUK-BTOG2-LU3005

EU-20510

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer.

Secondary

Compare symptom control and quality of life of patients treated with these regimens.
Compare response in patients treated with these regimens.
Compare the dose intensity of these regimens in these patients.
Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients.
Compare the intensity and number and duration of toxic episodes in patients treated with these regimens.
Compare cost and cost-effectiveness of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in arm I) IV over 1 hour on day 1.
Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1.

In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.

Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.

After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.

Enrollment

1,350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- Stage IIIB disease* that is not suitable for radical radiotherapy
- Stage IV disease* NOTE: *Radiographically verified
At least 1 measurable lesion by clinical examination or radiography
No mixed histologies of small cell lung cancer and NSCLC
No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

WHO 0-2

Life expectancy

At least 12 weeks

Hematopoietic

WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL

Hepatic

AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Alkaline phosphatase < 3 times ULN
Bilirubin < 1.5 times ULN

Renal

Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA clearance)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able and willing to participate in the quality of life assessment
No pre-existing neuropathy > grade 2
No other malignancy that would preclude study treatment or study comparisons
No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation
No psychiatric disorder that would preclude study participation
No other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy