NCT00129844

Brief Summary

The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
2 countries

16 active sites

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

First Submitted

Initial submission to the registry

August 10, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

Enrollment Period

1.7 years

First QC Date

August 10, 2005

Last Update Submit

August 19, 2008

Conditions

AdenocarcinomaNon-Small-Cell Lung CarcinomaLung Neoplasms

Keywords

Motexafin Gadoliniumnon-small cell, lung cancerLung cancercancer of the lungCarcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC

Secondary Outcomes (4)

  • To select the most effective regimen based on tumor response

  • To estimate the time to progression

  • To estimate survival

  • To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients

Interventions

Motexafin GadoliniumDRUG

Eligibility Criteria

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

You may qualify if:

  • \>18 years old
  • Histologically or cytologically confirmed diagnosis of NSCLC
  • Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • ECOG performance status score of 0 or 1
  • Willing and able to provide written informed consent

You may not qualify if:

  • Laboratory values of:
  • Absolute neutrophil count \< 1500/ul;
  • Platelet count \< 75,000/ul;
  • Hemoglobin \< 10 gm/dl;
  • AST or ALT \> 3 x the upper limit of normal (ULN);
  • Alkaline phosphatase \> 5 x ULN;
  • Bilirubin \> 2 x ULN;
  • Serum creatinine \> 2.0 mg/dL.
  • Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
  • Evidence of meningeal metastasis.
  • Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed \> 12 months prior to cytotoxic regimen).
  • Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment.
  • Significant weight loss \> 10% of body weight in preceding 6 weeks.
  • Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
  • Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Fountain Valley, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Palm Springs, California, United States

Location

Unknown Facility

Columbia, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Kingston, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

AdenocarcinomaCarcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Robert Natale, M.D.

    Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2005

First Posted

August 12, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

December 1, 2007

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

CA(5)US(11)