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

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 January 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 6, 2003
Last updated: September 19, 2013
Last verified: January 2009

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.

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 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)

Resource links provided by NLM:

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

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

Estimated Enrollment: 400
Study Start Date: November 2002
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


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


  • 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



  • 18 and over

Performance status

  • Karnofsky 50-100%

Life expectancy

  • At least 12 weeks


  • 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


  • 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)


  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 60 mL/min


  • 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


Biologic therapy

  • Not specified


  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy during or for 7 days after study therapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy
  • No concurrent radiotherapy during or for 7 days after study therapy


  • See Disease Characteristics


  • At least 12 weeks since prior investigational agents
  • No other concurrent antitumor therapy
  • No concurrent experimental medications
  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: NCT00055965

United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
The Christie NHS Foundation Trust
Study Chair: Nick Thatcher, PhD, FRCP The Christie NHS Foundation Trust
  More Information Identifier: NCT00055965     History of Changes
Other Study ID Numbers: CDR0000271903
Study First Received: March 6, 2003
Last Updated: September 19, 2013

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
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 23, 2017