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Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129844
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : August 20, 2008
Information provided by:
Pharmacyclics LLC.

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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Non-Small-Cell Lung Carcinoma Lung Neoplasms Drug: Motexafin Gadolinium Phase 2

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
Study Start Date : September 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC

Secondary Outcome Measures :
  1. To select the most effective regimen based on tumor response
  2. To estimate the time to progression
  3. To estimate survival
  4. To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129844

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United States, California
Fountain Valley, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
United States, Missouri
Columbia, Missouri, United States
St. Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Akron, Ohio, United States
United States, Tennessee
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, Ontario
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Pharmacyclics LLC.
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Study Chair: Robert Natale, M.D. Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center

Layout table for additonal information Identifier: NCT00129844    
Other Study ID Numbers: PCYC-0227
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2008
Keywords provided by Pharmacyclics LLC.:
Motexafin Gadolinium
non-small cell, lung cancer
Lung cancer
cancer of the lung
Carcinoma, Non-Small-Cell Lung
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents