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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 2, 2005
Last updated: August 23, 2013
Last verified: May 2007

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.

Condition Intervention Phase
Lung Cancer Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Length of survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1350
Study Start Date: March 2005
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 12 weeks


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


  • 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


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


  • 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


Biologic therapy

  • No concurrent immunotherapy


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

Endocrine therapy

  • No concurrent hormonal therapy except contraceptives or replacement steroids


  • No prior radiotherapy


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


  • More than 12 weeks since prior investigational agents and recovered
  • No other concurrent specific antitumor therapy
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00112710

United Kingdom
Institute of Clinical Research - Birmingham Recruiting
Birmingham, England, United Kingdom, B15 2TT
Contact: Hugh Jarrett    44-121-414-6425      
Birmingham Heartlands Hospital Recruiting
Birmingham, England, United Kingdom, B9 5SS
Contact: Joyce Thompson    44-121-766-6611      
Sponsors and Collaborators
University Hospital Birmingham
Study Chair: Hugh Jarrett Institute of Clinical Research - Birmingham
  More Information Identifier: NCT00112710     History of Changes
Other Study ID Numbers: CDR0000429610
Study First Received: June 2, 2005
Last Updated: August 23, 2013

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017