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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00373204
First received: September 5, 2006
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Motexafin Gadolinium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered motexafin gadolinium (MGd) and docetaxel [ Time Frame: up to 12 cycles ] [ Designated as safety issue: No ]
    The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.


Secondary Outcome Measures:
  • To estimate the time of progression [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]
    The progression is defined as the time fromfirst does of MGd to first eviedence of progression

  • To estimate overall survival [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]
    The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel

  • To estimate progression-free survival [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]
    Progression-free survival is defined as the time from first does of MGd to the earlier of progression

  • To estimate duration of response (CR + PR) [ Time Frame: Up to 12 cycles ] [ Designated as safety issue: Yes ]
    Duration of response (CR +PR) is defined as the time from the fisrt response to the time of disease progression.

  • To estimate clinical benefit rate (CR + PR + stable disease [SD]) [ Time Frame: up to 12 cycles ] [ Designated as safety issue: Yes ]
    The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation

  • To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC [ Time Frame: Up to 12 cycles ] [ Designated as safety issue: Yes ]
    All patients who receive at one dose of MGd will be included in the safety summaries and analyses


Enrollment: 50
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MGd and Docetaxtel

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.

  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
  • 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
  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: NCT00373204

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

No publications provided

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00373204     History of Changes
Other Study ID Numbers: PCYC-0229
Study First Received: September 5, 2006
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014