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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
carboplatin
cisplatin
gemcitabine hydrochloride
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christie Hospital NHS Trust

Outcomes

Primary Outcome Measures

Rate of hospitalization due to toxicity

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2003
Last Updated
September 19, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00055965
Brief Title
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Rate of hospitalization due to toxicity
Secondary Outcome Measure Information:
Title
Need for hospitalization for chemotherapy administration
Title
Tumor response rate
Title
Overall survival
Title
Relief of tumor-related symptoms
Title
Effect on Karnofsky performance status
Title
Toxicity as measured by NCIC CTC v2.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Thatcher, PhD, FRCP
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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

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