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

Sponsor:	Christie Hospital NHS Foundation Trust
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022009

Purpose

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 II Phase III

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

Study Start Date:

July 2001

Detailed Description:

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022009

Locations

United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators

Christie Hospital NHS Foundation Trust

Investigators

Study Chair:

Nick Thatcher, PhD, FRCP

Christie Hospital NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00022009 History of Changes
Other Study ID Numbers:	CDR0000068683, CHNT-GEM, EU-20062
Study First Received:	August 10, 2001
Last Updated:	July 23, 2008
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012