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Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer


Preclinical and clinical data suggest that MGd has activity in NSCLC and that the
combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial,
patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing
regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial
design will be used; if at least 4 out of 39 evaluable patients in the first stage of the
trial demonstrate objective clinical response, the study will proceed to Stage 2, where an
additional 22 evaluable patients will be enrolled following the same treatment regimen and
assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue
dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or
end of study.


Inclusion Criteria:



- ≥ 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

Exclusion Criteria:

- 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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

up to 12 cycles

Safety Issue:

No

Principal Investigator

Kishan Pandya, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester, Rochester, NY, USA

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0229

NCT ID:

NCT00373204

Start Date:

May 2006

Completion Date:

May 2008

Related Keywords:

  • Lung Cancer
  • Advanced non-small cell lung cancer
  • Non-small cell lung cancer
  • Lung cancer
  • Metastatic lung cancer
  • Second line treatment for advanced lung cancer
  • Cancer
  • Advanced lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
University of Rochester Rochester, New York  14642
The Cleveland Clinic Foundation Cleveland, Ohio  
Wilshire Oncology Medical Group Glendora, California  91741
University of Cincinnati Cincinnati, Ohio  45267-0502
Tri-County Hematology & Oncology Associates Canton, Ohio  44718
Cancer Specialists of Tidewater Chesapeake, Virginia