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A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Pilot Phase II Protocol Of Arsenic Trioxide (Trisenox) In Subjects With Advanced Non-Small Cell Carcinoma Of The Lung


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.

Inclusion 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 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Dennie V. Jones, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas

Authority:

United States: Federal Government

Study ID:

02-402

NCT ID:

NCT00075426

Start Date:

November 2002

Completion Date:

July 2005

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas Medical BranchGalveston, Texas  77555-1329