NCT00075426

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

January 9, 2004

Last Update Submit

February 11, 2013

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Dennie V. Jones, MD

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

November 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

US(1)