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Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer Clinical research trials and Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer. Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer  Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
For Condition: Recurrent Small Cell Lung Cancer,intermediate type small cell lung cancer
Status: Suspended
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer.
Details: OBJECTIVES: - Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer. - Determine the time to progression and overall survival in patients treated with this drug. - Assess quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy). Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter. Patients are followed at 30 days and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) 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 relapsed or progressive small cell lung cancer - Classical or intermediate variant OR - Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin - Bidimensionally measurable disease - At least 1 cm by 1 cm by physical exam or radiologic exam - Outside prior radiation port unless clinical evidence of disease progression - Previously radiated brain metastases allowed provided stable or improved PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 5 times ULN Renal: - Creatinine no greater than 2 mg/dL Other: - HIV negative - No AIDS-related illness - No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction) - No active nonmalignant systemic disease that would preclude study - No other active invasive malignancy within the past year or concurrently requiring ongoing treatment - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy - No concurrent immunotherapy - No concurrent biologic therapy - Concurrent epoetin alfa allowed Chemotherapy: - At least 4 weeks since prior chemotherapy - No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease - No other concurrent chemotherapy Endocrine therapy: - Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone) Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy to 15% or more of bone marrow - At least 1 week since prior radiotherapy to less than 15% of bone marrow - No prior radiotherapy to 50% or more of bone marrow - No concurrent radiotherapy Surgery: - Not specified Other: - Recovered from prior therapy - No other concurrent investigational drugs - Concurrent pamidronate allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026-1186
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Central Montgomery Medical Center
Lansdale, Pennsylvania, 19446-1200
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000068844; SPRI-H-P00740,FCCC-01020,NCI-G01-2005
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022711
Other Recurrent Small Cell Lung Cancer Studies:
1. Interferon alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
2. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
3. Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
4. Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer
5. Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other New Jersey Clinical Trials
Other Red Bank Clinical Trials
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer
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