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Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin Clinical research trials and Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin clinical trial. Test subjects typically receive the most effective healthcare possible for their Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin  Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
For Condition: stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: 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. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects. PURPOSE: Randomizedphase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectablestage III or stage IV non-small cell lung cancer.
Details: OBJECTIVES: - Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin. - Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens. - Compare the tumor response rate of patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the relief of tumor-related symptoms in patients treated with these regimens. - Compare the effect on Karnofsky performance status in patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 6 months and then every 3-4 months thereafter. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed inoperable non-small cell lung cancer - Stage IIIA, IIIB, or IV - Not eligible for curative radiotherapy or surgery - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 50-100% Life expectancy - At least 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal - Creatinine no greater than ULN OR - Creatinine clearance at least 60 mL/min Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after study completion - No active infection - No serious systemic disorder that would preclude study participation - No grade 2 or greater peripheral neuropathy - No significant neurological problems (e.g., seizures or psychiatric disorders) - No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy - No other concurrent chemotherapy during or for 7 days after study therapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy - No concurrent radiotherapy during or for 7 days after study therapy Surgery - See Disease Characteristics Other - At least 12 weeks since prior investigational agents - No other concurrent antitumor therapy - No concurrent experimental medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NickThatcher, Study Chair, Christie Hospital N.H.S. Trust
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Nick Thatcher 44-161-446-3000
Additional Information:
Study ID Numbers: CDR0000271903; EU-20245,CHNT-GEM-HOSP
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055965
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
4. Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
5. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
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