NCT00373204

Brief Summary

The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
4 countries

22 active sites

Status
terminated

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

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

September 5, 2006

Last Update Submit

July 23, 2014

Conditions

Lung Cancer

Keywords

Advanced non-small cell lung cancerNon-small cell lung cancerLung cancerMetastatic lung cancerSecond line treatment for advanced lung cancerCancerAdvanced lung cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel

    The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.

    up to 12 cycles

Secondary Outcomes (6)

  • To estimate the time of progression

    up to 12 cycles

  • To estimate overall survival

    up to 12 cycles

  • To estimate progression-free survival

    up to 12 cycles

  • To estimate duration of response (CR + PR)

    Up to 12 cycles

  • To estimate clinical benefit rate (CR + PR + stable disease [SD])

    up to 12 cycles

  • +1 more secondary outcomes

Study Arms (1)

Xcytrin® (motexafin gadolinium)

EXPERIMENTAL
Drug: Motexafin Gadolinium

Interventions

Motexafin GadoliniumDRUG

On Day 1 of each 3 week cycle for up to 12 cycles: MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.

Also known as: MGd and Docetaxtel
Xcytrin® (motexafin gadolinium)

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
  • Inoperable Stage IIIA, unresectable Stage IIIB or metastatic NSCLC patients who have received 1 prior platinum-based chemotherapy regimen
  • Measurable disease per RECIST
  • ECOG performance status score of 0 or 1
  • Willing and able to provide written informed consent

You may not qualify if:

  • Laboratory values of: ANC \< 1500/mm³, Platelet count \< 100,000/mm³, hemoglobin \< 10 g/dL, AST or ALT \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase \> 5 x ULN, bilirubin \> 1.5 x ULN, serum creatinine \> 2.0 mg/dL (176 umol/dL), albumin \< 3.0 g/dL (30 g/L)
  • Symptomatic or uncontrolled (untreated or treated and progressing) brain metastases
  • Evidence of meningeal metastasis
  • \> 1 prior cytotoxic regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed \> 12 months prior to cytotoxic regimen, or prior MGd)
  • 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 within preceding 6 weeks
  • Treatment for another cancer within 3 years before enrollment, except basal cell carcinoma of the skin or cervical cancer in situ
  • Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association Class III or IV
  • Uncontrolled hypertension (systolic blood pressure \> 160 mm Hg and diastolic blood pressure \> 110 mm Hg on maximal medical therapy)
  • Known history of porphyria (testing not required at screening visit)
  • Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit)
  • History of hypersensitivity to taxanes or polysorbate 80
  • Known history of HIV infection (testing not required at screening visit)
  • Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential)
  • Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Wilshire Oncology Medical Group

La Verne, California, United States

Location

University of Rochester

Rochester, New York, United States

Location

Tri-County Hematology & Oncology Associates

Canton, Ohio, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

Location

Cancer Specialists of Tidewater

Chesapeake, Virginia, United States

Location

Cancer Centre of Southeastern Ontario

Kingston, Ontario, Canada

Location

Hospital Charles Lemoyne

Greenfield Park, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, Russia

Location

Blokhin Cancer Research Center (Dept. of Chemotherapy)

Moscow, Russia

Location

Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)

Moscow, Russia

Location

Central Clinical Hospital

Moscow, Russia

Location

Moscow Oncology Hospital #62

Moscow, Russia

Location

St. Petersburg City Oncology Center

Saint Petersburg, Russia

Location

Samara Regional Oncology Center

Samara, Russia

Location

Regional Oncology Dispensary

Yaroslavl, Russia

Location

Clinic for Pulmonary Diseases, Military Medical Academy

Belgrade, Serbia

Location

Clinic for Pulmonary Diseases

Belgrade, Serbia

Location

Institute for Oncology and Radiology of Serbia

Belgrade, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, Serbia

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kishan Pandya, MD

    University of Rochester, Rochester, NY, USA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

May 1, 2006

Primary Completion

February 1, 2008

Study Completion

May 1, 2008

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

SE(4)US(7)RU(8)CA(3)