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Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: arsenic trioxide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
Dennie V. Jones, MD, Study Chair, Affiliation: University of Texas

Summary

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Texas Medical Branch, Galveston, Texas 77555-0209, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2002
Last updated: February 11, 2013

Page last updated: August 23, 2015

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