Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin

The Christie NHS Foundation Trust

Status and phase

Unknown

Phase 3

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: cisplatin

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00055965

CDR0000271903

EU-20245

CHNT-GEM-HOSP

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 if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.

PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.

Full description

OBJECTIVES:

Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin.
Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens.
Compare the tumor response rate of patients treated with these regimens.
Compare the overall survival of patients treated with these regimens.
Compare the relief of tumor-related symptoms in patients treated with these regimens.
Compare the effect on Karnofsky performance status in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8.
Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1.

In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 6 months and then every 3-4 months thereafter.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed inoperable non-small cell lung cancer
- Stage IIIA, IIIB, or IV
- Not eligible for curative radiotherapy or surgery
No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 50-100%

Life expectancy

At least 12 weeks

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST no greater than 2.5 times ULN
Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)

Renal

Creatinine no greater than ULN OR
Creatinine clearance at least 60 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception during and for 3 months after study completion
No active infection
No serious systemic disorder that would preclude study participation
No grade 2 or greater peripheral neuropathy
No significant neurological problems (e.g., seizures or psychiatric disorders)
No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy