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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Motexafin Gadolinium

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Cancer Centre of Southeastern Ontario
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Hospital Charles LeMoyne
    • Montreal, Quebec, Canada
      • Jewish General Hospital
• Russian Federation
  • Chelyabinsk, Russian Federation
    • Chelyabinsk Regional Oncology Dispensary
  • Moscow, Russian Federation
    • Blokhin Cancer Research Center (Dept. of Chemotherapy)
  • Moscow, Russian Federation
    • Blokhin Cancer Research Center (Dept. of Clinical Pharmacology and Chemotherapy)
  • Moscow, Russian Federation
    • Central Clinical Hospital
  • Moscow, Russian Federation
    • Moscow Oncology Hospital #62
  • Samara, Russian Federation
    • Samara Regional Oncology Center
  • St. Petersburg, Russian Federation
    • St. Petersburg City Oncology Center
  • Yaroslavl, Russian Federation
    • Regional Oncology Dispensary
• Serbia
  • Belgrade, Serbia
    • Clinic for Pulmonary Diseases, Military Medical Academy
  • Belgrade, Serbia
    • Clinic for Pulmonary Diseases
  • Belgrade, Serbia
    • Institute for Oncology and Radiology of Serbia
  • Sremska Kamenica, Serbia
    • Institute For Pulmonary Diseases of Vojvodina
• United States
  • California
    • La Verne, California, United States
      • Wilshire Oncology Medical Group
  • New York
    • Rochester, New York, United States
      • University of Rochester
  • Ohio
    • Canton, Ohio, United States
      • Tri-County Hematology & Oncology Associates
    • Cincinnati, Ohio, United States
      • University of Cincinnati
    • Cleveland, Ohio, United States
      • The Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Pennsylvania Oncology Hematology Associates
  • Virginia
    • Chesapeake, Virginia, United States
      • Cancer Specialists of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xcytrin® (motexafin gadolinium)	Drug: 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.; Other Names: MGd and Docetaxtel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel	The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.	up to 12 cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the time of progression	The progression is defined as the time fromfirst does of MGd to first eviedence of progression	up to 12 cycles
To estimate overall survival	The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel	up to 12 cycles
To estimate progression-free survival	Progression-free survival is defined as the time from first does of MGd to the earlier of progression	up to 12 cycles
To estimate duration of response (CR + PR)	Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.	Up to 12 cycles
To estimate clinical benefit rate (CR + PR + stable disease [SD])	The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation	up to 12 cycles
To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC	All patients who receive at one dose of MGd will be included in the safety summaries and analyses	Up to 12 cycles

Collaborators and Investigators

• Sponsor: Pharmacyclics LLC.
• Investigators: Study Chair: Kishan Pandya, MD, University of Rochester, Rochester, NY, USA

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: September 5, 2006
• First Submitted That Met QC Criteria: September 6, 2006
• First Posted (Estimate): September 7, 2006

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Non-small cell lung cancer; Lung cancer; Advanced non-small cell lung cancer; Metastatic lung cancer; Second line treatment for advanced lung cancer; Advanced lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Photosensitizing Agents; Dermatologic Agents; Motexafin gadolinium
• Other Study ID Numbers: PCYC-0229