NCT00022009

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
Last Updated

September 20, 2013

Status Verified

October 1, 2002

First QC Date

August 10, 2001

Last Update Submit

September 19, 2013

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Nick Thatcher, PhD, FRCP

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

June 12, 2003

Study Start

July 1, 2001

Last Updated

September 20, 2013

Record last verified: 2002-10

Locations

GB(1)