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: March 18, 2014
Last verified: March 2014

September 5, 2006
March 18, 2014
May 2006
February 2008   (final data collection date for primary 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 [ 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.
To assess the complete and partial response rate (CR and PR) in patients with advanced NSCLC when administered MGd and Docetaxel.
Complete list of historical versions of study NCT00373204 on ClinicalTrials.gov Archive Site
  • 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
  • To estimate the time to progression.
  • To estimate overall survival.
  • To estimate progression-free survival.
  • To estimate duration of response (CR + PR)
  • To estimate clinical benefit rate (CR + PR + stable disease).
  • To evaluate the safety and tolerability of the combination of MGd and docetaxel in advanced NSCLC patients.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
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
Experimental: Xcytrin® (motexafin gadolinium)
Intervention: Drug: Motexafin Gadolinium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
May 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Russian Federation,   Serbia
 
NCT00373204
PCYC-0229
Not Provided
Pharmacyclics
Pharmacyclics
Not Provided
Study Chair: Kishan Pandya, MD University of Rochester, Rochester, NY, USA
Pharmacyclics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP