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T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy Clinical research trials and T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy medical trials happen in hundreds of localities 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 measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy. T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy clinical trial. Participants frequently obtain the most expert healthcare available for their T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy  T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
For Condition: stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Tularik ,
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 T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane when treated with T138067 sodium. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the number of patients who progress when treated with this drug. IV. Determine the duration of response, time to disease progression, and median survival of patients treated with this drug. V. Correlate the toxic effects of this drug with peak plasma levels in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive T138067 sodium IV over 3 hours on days 1, 8, and 15. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months after study completion. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed non-small cell lung cancer (NSCLC); Locally advanced or metastatic disease - Received a prior first-line taxane (as a single agent or component of a combination regimen) as the only chemotherapy for locally advanced or metastatic disease; Any amount of prior adjuvant chemotherapy allowed - Bidimensionally measurable disease outside the field of prior radiotherapy; Amenable to radiologic imaging techniques - No clinically apparent CNS metastases or carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy or therapeutic biologic response modifiers; No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim; No concurrent epoetin alfa - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered; No other concurrent cytotoxic chemotherapy - Endocrine therapy: No concurrent hormonal therapy for NSCLC - Radiotherapy: See Disease Characteristics; At least 2 weeks since prior limited-field radiotherapy not involving the hematopoietic bone marrow and recovered; At least 4 weeks since prior radiotherapy to no more than 25% of the hematopoietic bone marrow and recovered; No prior wide-field radiotherapy to the pelvis; No concurrent radiotherapy (including palliative radiotherapy) - Surgery: At least 4 weeks since prior major surgery - Other: At least 4 weeks since prior investigational agents; No concurrent anticonvulsants unless required for study drug-related toxicity; No concurrent high-dose acetaminophen (i.e., at least 4 g/day); No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 3 times ULN; Albumin greater than 2.5 g/dL; No history of Gilbert's syndrome - Renal: Creatinine no greater than 1.5 times ULN - Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No other severe disease, infection, or comorbidity that would preclude study participation; No known defect of glutathione metabolism; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SeanMcCarthy, Study Chair, Tularik
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Additional Information:
Study ID Numbers: CDR0000068798; VU-000511,TULA-T2002
Study Start Date: October 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022243
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer
2. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
3. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
5. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
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T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
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