Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00365183
First received: August 15, 2006
Last updated: October 29, 2013
Last verified: October 2013

August 15, 2006
October 29, 2013
June 2006
January 2008   (final data collection date for primary outcome measure)
6 month progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
6 month progression free survival
Complete list of historical versions of study NCT00365183 on ClinicalTrials.gov Archive Site
  • Time to disease progression [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Time to progression is defined as the time from first dose of MGd to first evidence of progression.
  • Overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
  • Progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
  • Response rate (CR+PR) by RECIST criteria [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
  • Duaration of reponse (CR+PR) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
  • Clinical benefit rate (CR+PR+SD) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
  • Safety and tolerability of MGd and pemetrexed [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    All patients who receive any MGd will be included in the safety summaries and analyses
To estimate: Time to progression, Overall survival, Progression free survival, Overall response rate, Duration of response, Clinical benefit rate, Safety and tolerability of the combination of motexafin gadolinium and pemetrexed
Not Provided
Not Provided
 
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

The goals of this study are:

  • to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
  • to assess response to treatment in patients with NSCLC six months after beginning study treatment.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Carcinoma
Drug: Motexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Other Name: MGd and Alimta®
Experimental: Xcytrin® (motexafin gadolinium)
Intervention: Drug: Motexafin gadolinium and pemetrexed

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
74
June 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
  • ECOG performance status score of 0 or 1

Exclusion Criteria:

  • Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
  • Symptomatic or uncontrolled brain metastases
  • Evidence of meningeal metastasis
  • > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
  • Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365183
PCYC-0228
Not Provided
Pharmacyclics
Pharmacyclics
Not Provided
Study Chair: Martin Edelman, MD University of Maryland, Greenbaum Cancer Center
Pharmacyclics
October 2013

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