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

August 23, 2013 updated by: University Hospital Birmingham

A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

1350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • Recruiting
        • Birmingham Heartlands Hospital
        • Contact:
          • Joyce Thompson
          • Phone Number: 44-121-766-6611
      • Birmingham, England, United Kingdom, B15 2TT
        • Recruiting
        • Institute of Clinical Research - Birmingham
        • Contact:
          • Hugh Jarrett
          • Phone Number: 44-121-414-6425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except contraceptives or replacement steroids

Radiotherapy

  • No prior radiotherapy

Surgery

  • Recovered from prior surgery
  • Prior surgical resection for NSCLC allowed

Other

  • More than 12 weeks since prior investigational agents and recovered
  • No other concurrent specific antitumor therapy
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of survival

Secondary Outcome Measures

Outcome Measure
Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire
Treatment response as measured by RECIST criteria
Dose intensity of chemotherapy
Ratio of treatment courses given as in-patient versus out-patient
Toxicity as measured by CTCAE v3.0
Treatment cost

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Investigators

  • Study Chair: Hugh Jarrett, Institute of Clinical Research - Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Registration Dates

First Submitted

June 2, 2005

First Submitted That Met QC Criteria

June 2, 2005

First Posted (Estimate)

June 3, 2005

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000429610
  • CRUK-BTOG2-LU3005
  • EU-20510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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