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Status:

UNKNOWN

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

Lead Sponsor:

University Hospital Birmingham

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 d...

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 ce...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    1350 Patients enrolled

    Trial Details

    Trial ID

    NCT00112710

    Start Date

    March 1 2005

    Last Update

    August 26 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Institute of Clinical Research - Birmingham

    Birmingham, England, United Kingdom, B15 2TT

    2

    Birmingham Heartlands Hospital

    Birmingham, England, United Kingdom, B9 5SS