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Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer  Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): University of Texas ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have locally advanced or metastaticnon-small cell lung cancer.
Details: OBJECTIVES: Primary - Determine the safety and activity of arsenic trioxide in patients with locally advanced or metastatic non-small cell lung cancer. - Determine the qualitative and quantitative toxic effects of this drug in these patients. Secondary - Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug. - Determine the patterns of failure and survival in patients treated with this drug. OUTLINE: This is a pilot study. Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy beyond CR. Patients achieving CR due to local consolidative therapy (surgery or radiotherapy) receive 2 additional courses of therapy beyond CR. Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC), meeting criteria for 1 of the following: - Locally advanced disease not amenable to radiotherapy or surgery - Metastatic disease - Received at least 1 course of platinum-based (e.g., cisplatin or carboplatin) chemotherapy - No uncontrolled CNS metastases - Ineligible for higher priority treatment protocols PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Zubrod 0-1 OR - SWOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times normal - SGOT and SGPT no greater than 3 times normal Renal - Creatinine no greater than 2.0 mg/dL - Calcium no greater than 12 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No uncontrolled, clinically significant dysrhythmia - Cardiac ejection fraction greater than 50% Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Electrolytes (including magnesium) normal - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No prior or ongoing peripheral neuropathy grade 2 or greater - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent cytokine therapy Chemotherapy - See Disease Characteristics - No more than 2 prior chemotherapy regimens for NSCLC - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 2 weeks since prior radiotherapy - No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion - No concurrent radiotherapy - Concurrent palliative or emergent radiotherapy allowed Surgery - More than 2 weeks since prior surgery Other - At least 4 weeks since prior antineoplastic agents for non-malignant conditions (e.g., methotrexate for rheumatoid arthritis) - No concurrent antineoplastic agents for non-malignant conditions
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DennieJones, Study Chair, University of Texas
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Dennie Jones 409-772-1165
Additional Information:
Study ID Numbers: CDR0000346366; UTMB-02402
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075426
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
3. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
4. Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV 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 3B non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials
Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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