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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022009
First received: August 10, 2001
Last updated: September 19, 2013
Last verified: October 2002

August 10, 2001
September 19, 2013
July 2001
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Complete list of historical versions of study NCT00022009 on ClinicalTrials.gov Archive Site
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Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 40-70%

Life expectancy:

  • At least 4 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 times normal

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent systemic chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Concurrent palliative surgery allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00022009
CDR0000068683, CHNT-GEM, EU-20062
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Christie Hospital NHS Foundation Trust
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Study Chair: Nick Thatcher, PhD, FRCP Christie Hospital NHS Foundation Trust
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP