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



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

For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Christie Hospital N.H.S. Trust ,
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Compare the toxicity of these regimens in these patients. III. Compare the overall survival of patients treated with these regimens. IV. Compare the response rate in patients treated with these regimens. PROTOCOL 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
NickThatcher,  Study Chair,  Christie Hospital N.H.S. Trust

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


Additional Information:
Study ID Numbers:  CDR0000068683;  CHNT-GEM,EU-20062
Study Start Date: July 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022009

Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

2. Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

3. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

4. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

5. Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

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