Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)

NCT ID: NCT00373204

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-05-31

Brief Summary

The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xcytrin® (motexafin gadolinium)

Group Type: EXPERIMENTAL

Motexafin Gadolinium

Intervention Type: DRUG

On Day 1 of each 3 week cycle for up to 12 cycles:

MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.

Interventions

Motexafin Gadolinium

On Day 1 of each 3 week cycle for up to 12 cycles:

MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.

Intervention Type: DRUG

Other Intervention Names

MGd and Docetaxtel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kishan Pandya, MD

Role: STUDY_CHAIR

University of Rochester, Rochester, NY, USA

Locations

Wilshire Oncology Medical Group

La Verne, California, United States

University of Rochester

Rochester, New York, United States

Tri-County Hematology & Oncology Associates

Canton, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

Cancer Specialists of Tidewater

Chesapeake, Virginia, United States

Cancer Centre of Southeastern Ontario

Kingston, Ontario, Canada

Hospital Charles Lemoyne

Greenfield Park, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, , Russia

Blokhin Cancer Research Center (Dept. of Chemotherapy)

Moscow, , Russia

Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)

Moscow, , Russia

Central Clinical Hospital

Moscow, , Russia

Moscow Oncology Hospital #62

Moscow, , Russia

St. Petersburg City Oncology Center

Saint Petersburg, , Russia

Samara Regional Oncology Center

Samara, , Russia

Regional Oncology Dispensary

Yaroslavl, , Russia

Clinic for Pulmonary Diseases, Military Medical Academy

Belgrade, , Serbia

Clinic for Pulmonary Diseases

Belgrade, , Serbia

Institute for Oncology and Radiology of Serbia

Belgrade, , Serbia

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

Countries

United States; Canada; Russia; Serbia

Other Identifiers

PCYC-0229

Identifier Type: -

Identifier Source: org_study_id