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

Non-Small Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00365183
• Other study ID #: PCYC-0228
• Status: Terminated
• Phase: Phase 2
• First received: August 15, 2006
• Last updated: October 29, 2013
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2013
• Source: Pharmacyclics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: June 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

References & Publications (2)

Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. Epub 2004 Jan 8. Review. — View Citation

Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month progression free survival	proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.	up to 2 years	No
Secondary	Time to disease progression	Time to progression is defined as the time from first dose of MGd to first evidence of progression.	up to 2 years	Yes
Secondary	Overall survival	Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.	up to 2 years	Yes
Secondary	Progression free survival	Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.	up to 2 years	Yes
Secondary	Response rate (CR+PR) by RECIST criteria	Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.	up to 2 years	Yes
Secondary	Duaration of reponse (CR+PR)	Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.	up to 2 years	Yes
Secondary	Clinical benefit rate (CR+PR+SD)	Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment	up to 2 years	Yes
Secondary	Safety and tolerability of MGd and pemetrexed	All patients who receive any MGd will be included in the safety summaries and analyses	up to 2 years	Yes