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Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma, Non-Small-Cell Lung Carcinoma, Lung Neoplasms

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Trial Information

Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer


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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Robert Natale, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

December 2007

Related Keywords:

  • Adenocarcinoma
  • Non-Small-Cell Lung Carcinoma
  • Lung Neoplasms
  • Motexafin Gadolinium
  • non-small cell, lung cancer
  • Lung cancer
  • cancer of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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