Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2001
Last updated: September 19, 2013
Last verified: October 2002

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment.

PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

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

Study Start Date: July 2001
Detailed Description:


  • Compare quality of life, in terms of the degree of symptom palliation and improvements in performance status, of patients with locally advanced or metastatic poor prognosis non-small cell lung cancer treated with 2 schedules of gemcitabine combined with best supportive care.
  • Compare the toxicity of these regimens in these patients.
  • Compare the overall survival of patients treated with these regimens.
  • Compare the response rate in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once a week for 3 weeks. Treatment continues every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 30 minutes once a week for 2 weeks. Treatment continues every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients on both arms also receive best supportive care. Additional courses of gemcitabine may be administered at the discretion of the investigator.

Quality of life is assessed at baseline and then after each course of chemotherapy.

Patients are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 174 patients (87 per treatment arm) will be accrued for this study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically or cytologically proven locally advanced or metastatic non-small cell lung cancer that is not amenable to curative surgery or radiotherapy
  • No known CNS metastases
  • No concurrent cord compression or superior vena cava syndrome requiring immediate radiotherapy



  • 18 and over

Performance status:

  • Karnofsky 40-70%

Life expectancy:

  • At least 4 weeks


  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10.0 g/dL


  • Bilirubin no greater than 3 times normal
  • ALT and AST no greater than 3 times normal (5 times normal if liver metastasis present)


  • Creatinine no greater than 1.5 times normal


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 3 months after study
  • No active infection
  • No other concurrent serious, systemic disorder that would preclude study


Biologic therapy:

  • Not specified


  • No prior chemotherapy
  • No other concurrent systemic chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed


  • See Disease Characteristics
  • Concurrent palliative radiotherapy allowed
  • No concurrent curative radiotherapy


  • See Disease Characteristics
  • Concurrent palliative surgery allowed
  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: NCT00022009

United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
Study Chair: Nick Thatcher, PhD, FRCP Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided Identifier: NCT00022009     History of Changes
Other Study ID Numbers: CDR0000068683, CHNT-GEM, EU-20062
Study First Received: August 10, 2001
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on March 03, 2015