NCT00033410

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer.

Trial Health

80
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_1 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

September 1, 2006

First QC Date

April 9, 2002

Last Update Submit

February 6, 2009

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancersquamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lung

Interventions

carboplatinDRUG
paclitaxelDRUG
tirapazamineDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary bronchogenic non-small cell lung cancer * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Stage IIIA or IIIB disease (T1-4, N2-3) * Mediastinal lymph nodes at least 2 cm in diameter by radiography sufficient to stage N2-3 (must be node positive \[cytologically or histologically confirmed\] if largest mediastinal node is less than 2 cm in diameter) OR * Selected stage IIB disease (T3, N0 or T3, N1 with a medical condition that precludes surgery) * No malignant pleural effusion * Measurable or evaluable disease by chest x-ray or CT scan * No metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count normal Hepatic: * Not specified Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled congestive heart failure * No unstable angina * No unstable cardiac arrhythmias Pulmonary: * FEV\_1 at least 1.0 L Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant hearing loss PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for lung cancer Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for lung cancer Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

CarboplatinPaclitaxelTirapazamineRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTriazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Derick H. Lau, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Last Updated

February 9, 2009

Record last verified: 2006-09

Locations

US(2)