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Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy Clinical research trials and Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy clinical trial. Participants oftentimes recieve the most expert healthcare available for their Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy  Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of epothilone D in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
Details: OBJECTIVES: Primary - Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary - Determine the safety of this drug in these patients. - Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. - Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. - Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 patients 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 non-small cell lung cancer (NSCLC) - Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only - Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease - Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity - At least 1 site of unidimensionally measurable disease by physical exam or radiography - No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Hemoglobin 8 g/dL - Platelet count 75,000/mm^3 Hepatic - AST 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) - Alkaline phosphatase 5 times ULN - Bilirubin 1.8 mg/dL Renal - Creatinine 2.0 mg/dL Cardiovascular - No New York Heart Association class III or IV congestive heart failure - No personal or family history of congenital long QT syndrome - No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No preexisting neuropathy grade 2 - No other malignancy within the past 5 years except for the following: - Cured basal cell skin cancer - Carcinoma in situ of the cervix or urinary bladder - Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL - No hypersensitivity reaction grade 3 to prior Cremophor-containing therapy - No infection requiring parenteral or oral anti-infective therapy - No weight loss of 10% within the past 3 months - No altered mental status or psychiatric illness that would preclude giving informed consent - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) - No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics - At least 3 weeks since prior surgery and recovered Other - Prior adjuvant or neoadjuvant therapy allowed - Prior radiosensitizers allowed - At least 2 weeks since prior gefitinib - More than 3 weeks since prior investigational agents (therapeutic or diagnostic) - No other concurrent investigational agents - No other concurrent anticancer treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NaiyerRizvi, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Naiyer Rizvi 212-639-3204
Additional Information:
Study ID Numbers: CDR0000358910; KOS-201,MSKCC-03134,ROCHE-N017352
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081107
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
2. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
3. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Glufosfamide With of Without Hydration in Treating Patients With Advanced Non-small cell Lung Cancer
5. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
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Other New York City Clinical Trials
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
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