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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Texas
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Galveston, Texas, Stany Zjednoczone, 77555-0209
- University of Texas Medical Branch
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Maskowanie: Brak (otwarta etykieta)
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Dennie V. Jones, MD, University of Texas
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 02-402
- CDR0000346366
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