Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung
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: This phase II trial is studying how well arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
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Galveston, Texas, Förenta staterna, 77555-0209
- University of Texas Medical Branch
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 central nervous system (CNS) metastases
- Ineligible for higher priority treatment protocols
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-1 OR
- Zubrod Scale 0-1 OR
- South West Oncology Group (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
- Serum glutamate oxaloacetate transaminase (SGOT) and Serum glutamate pyruvate transaminase (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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Utredare
- Studiestol: Dennie V. Jones, MD, University of Texas
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 02-402
- CDR0000346366
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