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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373204
Recruitment Status : Terminated
First Posted : September 7, 2006
Last Update Posted : July 24, 2014
Information provided by (Responsible Party):
Pharmacyclics LLC.

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Motexafin Gadolinium Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

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 Name: MGd and Docetaxtel

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. To estimate the time of progression [ Time Frame: up to 12 cycles ]
    The progression is defined as the time fromfirst does of MGd to first eviedence of progression

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

  3. To estimate progression-free survival [ Time Frame: up to 12 cycles ]
    Progression-free survival is defined as the time from first does of MGd to the earlier of progression

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373204

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Sponsors and Collaborators
Pharmacyclics LLC.
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Study Chair: Kishan Pandya, MD University of Rochester, Rochester, NY, USA

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Responsible Party: Pharmacyclics LLC. Identifier: NCT00373204    
Other Study ID Numbers: PCYC-0229
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Pharmacyclics LLC.:
Advanced non-small cell lung cancer
Non-small cell lung cancer
Lung cancer
Metastatic lung cancer
Second line treatment for advanced lung cancer
Advanced lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Motexafin gadolinium
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Dermatologic Agents