Motexafin Gadolinium in Adenocarcinoma and Lung Neoplasms and Non-Small-Cell Lung Carcinoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Motexafin Gadolinium

Detailed Description

Outline:

Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:

Arm A - 10 mg/kg MGd once per week

Arm B - 15 mg/kg MGd once every 3 weeks

Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.

At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada
  - Edmonton, Alberta, Canada
- Ontario
  - Kingston, Ontario, Canada
  - Ottawa, Ontario, Canada
- Quebec
  - Montreal, Quebec, Canada
United States
- California
  - Fountain Valley, California, United States
  - Los Angeles, California, United States
  - Palm Springs, California, United States
- Missouri
  - Columbia, Missouri, United States
  - St. Louis, Missouri, United States
- Nebraska
  - Omaha, Nebraska, United States
- New Mexico
  - Albuquerque, New Mexico, United States
- New York
  - Rochester, New York, United States
- Ohio
  - Akron, Ohio, United States
- Tennessee
  - Knoxville, Tennessee, United States
  - Nashville, Tennessee, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

>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

Exclusion Criteria:

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.
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).
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.
Physical or mental condition that makes patient unable to complete specified follow-up assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Investigators

Study Chair: Robert Natale, M.D., Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 10, 2005

First Submitted That Met QC Criteria