NCT00005065

Brief Summary

Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA non-small cell lung cancer. 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. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

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

January 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

April 6, 2000

Last Update Submit

June 3, 2013

Conditions

Stage IIIA Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose, defined as that dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) graded according to CTC version 2.0

    Up to day 119

Secondary Outcomes (2)

  • Concentrations of gadolinium in tumor, tumor involved lymph nodes, normal lung, and blood

    Up to day 123

  • Image pixel intensities in tumor, tumor involved lymph nodes, normal lung, and blood obtained by 1.5 Tesla MRI

    Up to day 119

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy.

Drug: paclitaxelDrug: carboplatinDrug: motexafin gadoliniumProcedure: conventional surgeryRadiation: radiation therapy

Interventions

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm I
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Arm I
motexafin gadoliniumDRUG

Given IV

Also known as: gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120, Xcytrin
Arm I
conventional surgeryPROCEDURE

Undergo complete surgical resection

Also known as: surgery, conventional
Arm I
radiation therapyRADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed non-small cell carcinoma of the lung
  • Surgical staging with mediastinoscopy or anterior thoracotomy required
  • T1-T3, N2, M0
  • Must appear resectable
  • Performance status - Karnofsky 70-100%
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal
  • Creatinine no greater than 2 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • FEV greater than 0.8 L
  • Not pregnant or nursing
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelTaxesCarboplatinmotexafin gadoliniumSurgical Procedures, OperativeCongresses as TopicRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination ComplexesOrganizationsTherapeuticsPhysical Phenomena

Study Officials

  • John Grecula

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

May 7, 2003

Study Start

January 1, 2000

Primary Completion

December 1, 2003

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)