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Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer Clinical research trials and Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer. Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer  Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Ottawa Regional Cancer Centre ,
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 is a way to kill more tumor cells. PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer.
Details: OBJECTIVES: I. Estimate the maximum tolerated dose of hydroxyurea that can be given in combination with other chemotherapy regimens in patients with incurable non-small cell lung cancer. II. Determine the toxicity of this combination chemotherapy regimen in these patients. III. Observe the efficacy of hydroxyurea in patients with incurable non-small cell lung cancer refractory to front-line chemotherapy. PROTOCOL OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of hydroxyurea in combination with other chemotherapy. Groups of 3 patients take escalated doses of oral hydroxyurea three times weekly or daily throughout treatment with cisplatin plus (per their previous regimen) vinblastine, vindesine, vinorelbine, or etoposide. Treatment continues in responding and stable patients until 3 months beyond documentation of complete remission (minimum 4 courses), maximum of 6 courses beyond documentation of partial remission, or 3 courses beyond documentation of stable disease. Patients are followed every 3 weeks for 3 months, every 6 weeks for 3 months, then every 3 months until disease progression. PROJECTED ACCRUAL: An anticipated 15-30 patients will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histopathologically proven non-small cell lung cancer that is incurable by surgery or radiotherapy; Brain metastases allowed - Demonstrated resistance to prior chemotherapy required by 1 of the following: Tumor growth or recurrence while on treatment; Failure of tumor to shrink over 3 consecutive courses of treatment - Measurable or evaluable disease - Recovery from any treatment-limiting toxicity required --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 3 weeks since myelosuppressive chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin) - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since radiotherapy unless to a limb or limited treatment area - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: Greater than 12 weeks - Hematopoietic: ANC at least 1,500; Platelets at least 100,000; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL (26 micromoles/L); AST/ALT less than 1.5 times normal - Renal: Creatinine less than 1.6 mg/dL (150 micromoles/L) - Cardiovascular: No uncontrolled hypertension or other cardiac disease; No myocardial infarction within 6 months - Other: No uncontrolled diabetes; No active abuse of ethanol; No allergies to study medication; No active infection or other serious medical condition that precludes protocol treatment; No dementia or significantly altered mental status that precludes informed consent; No prior melanoma or malignancy of the following sites: Breast; Kidney; Thyroid; Salivary glands; Endometrium; No other second malignancy within 5 years except: Nonmelanomatous skin cancer; Carcinoma in situ of cervix - No pregnant or nursing women; Effective contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidStewart, Study Chair, Ottawa Regional Cancer Centre
Ottawa Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 1C4
Canada
Additional Information:
Study ID Numbers: CDR0000065207; CAN-OTT-9501,NCI-V96-1099
Study Start Date: July 1995
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002887
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
2. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
3. Paclitaxel in Treating Patients With Lung Cancer
4. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
5. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Ontario Clinical Trials
Other Ottawa Clinical Trials
Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
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