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

Study Overview
=================
Brief 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 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.

Detailed 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.

Official Title
-----------------
A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: carboplatin
* Drug: cisplatin
* Drug: gemcitabine hydrochloride


Participation Criteria
=================
Eligibility 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 Not specified Chemotherapy No prior cytotoxic chemotherapy No other concurrent chemotherapy during or for 7 days after study therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior radiotherapy No concurrent radiotherapy during or for 7 days after study therapy Surgery See Disease Characteristics Other At least 12 weeks since prior investigational agents No other concurrent antitumor therapy No concurrent experimental medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospitalization due to toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hospitalization for chemotherapy administration |  |  | 
| Tumor response rate |  |  | 
| Overall survival |  |  | 
| Relief of tumor-related symptoms |  |  | 
| Effect on Karnofsky performance status |  |  | 
| Toxicity as measured by NCIC CTC v2.0 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer