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

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00129844
First received: August 10, 2005
Last updated: August 19, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Adenocarcinoma
Non-Small-Cell Lung Carcinoma
Lung Neoplasms
Drug: Motexafin Gadolinium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 108
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129844

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

No publications provided

ClinicalTrials.gov Identifier: NCT00129844     History of Changes
Other Study ID Numbers: PCYC-0227
Study First Received: August 10, 2005
Last Updated: August 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Motexafin Gadolinium
non-small cell, lung cancer
Lung cancer
cancer of the lung
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 27, 2014